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Heggie et al ACPSEM Position Paper: Digital Mammography V3.

ACPSEM Position Paper


RECOMMENDATIONS FOR A DIGITAL MAMMOGRAPHY
QUALITY ASSURANCE PROGRAM V3.0
JCP Heggie1, ID McLean2, J Herley3, FJ Thomson 4, RK Grewal5, J Diffey5, and LT Collins5
1

BreastScreen Victoria, Carlton, Australia


Medical Physics and Radiation Engineering, Canberra Hospital, Australia
3
Queensland Health, Australia
4
Radiological Physics Consultants Ltd, New Zealand
5
Medical Physics Department, Westmead Hospital, Westmead, Australia
2

Abstract
In 2001 the ACPSEM published a position paper on quality assurance in screen film mammography which was
subsequently adopted as a basis for the quality assurance programs of both the Royal Australian and New
Zealand College of Radiologists (RANZCR) and of BreastScreen Australia. Since then the clinical
implementation of digital mammography has been realised and it has become evident that existing screen-film
protocols were not appropriate to assure the required image quality needed for reliable diagnosis or to address
the new dose implications resulting from digital technology. In addition, the advantages and responsibilities
inherent in teleradiology are most critical in mammography and also need to be addressed. The current
document is the result of a review of current overseas practice and local experience in these areas. At this time
the technology of digital imaging is undergoing significant development and there is still a lack of full
international consensus about some of the detailed Quality Control (QC) tests that should be included in quality
assurance (QA) programs. This document describes the current status in digital mammography QA and
recommends test procedures that may be suitable in the Australasian environment. For completeness, this
document also includes a review of the QA programs required for the various types of digital biopsy units used
in mammography. In the future, international harmonisation of digital quality assurance in mammography and
changes in the technology may require a review of this document. Accordingly, updates of this document will
be provided as deemed necessary in electronic format on the ACPSEMs website (see
http://www.acpsem.org.au/au/subgroup/radiology/RadiologySG_index.html). Version 2.0 represented the first
of these updates and key changes related to image quality evaluation, ghost image evaluation and interpretation
of contrast to noise ratio (now called signal to noise ratio) measurements. In Version 3.0 significant changes,
made in light of further experience gained in testing digital mammography equipment, are highlighted in
the body of the paper and in the Appendices by the use of red text. Changes to the facility QC tests have
been made to bring the suggested procedures in line with those most recently adopted by the Royal
Australian and New Zealand College of Radiologists.

Key Words

mammography, digital, quality control,


quality assurance, biopsy1

Table of Contents
1 Introduction
1.1 Background
1.2 Scope of this Document
2 Digital Mammography Equipment
2.1 Full Field Digital Mammographic (FFDM)
Units
2.1.1 Computed Radiography (CR)

2
2
3
3
3
3

Corresponding author: John CP Heggie, 32 Mercil Rd,


Alphington VIC 3078, Australia, Tel: +61 (3) 9497 5446,
Email: john.heggie@bigpond.com

2.1.2 Indirect Flat Panel Detectors


2.1.3 Direct Flat Panel Detectors
2.1.4 Scanning Photon Counting Systems
2.1.5 Digital Breast Tomosynthesis (DBT)
2.1.6 Digital Image Display Systems
2.1.7 Automatic Exposure Control (AEC)
2.2 System Types Included as Biopsy
Mammographic Units
2.3 The Role of the Medical Physicist
3 Facility Quality Control Procedures

4
4
5
5
6
6
6
7
7

3.1 Introduction
7
3.2 Procedure Recommendations
7
3.2.1 Viewing Conditions
7
3.2.2 Image Plate Erasure (CR only)
7
3.2.3 Full Field Artefact Evaluation & System Check
(DR systems only)
7
3.2.4 Monitor QC
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3.2.5
3.2.6
3.2.7
3.2.8

Monitor/Viewbox Cleaning
8
Printer Area Cleanliness
8
Image Quality Evaluation
8
Detector Calibration Flat Field Test (DR
Systems only)
9
6
3.2.9 Signal Difference to Noise Ratio (DR Systems
only)
9
3.2.10 Printer QC
9
3.2.11 Mechanical Inspection & Breast Thickness
Indication
10
3.2.12 Repeat Analysis
10
3.2.13 Image Receptor Homogeneity
10
3.2.14 AEC Calibration Test
10
3.2.15 Compression
11
3.2.16 Test Equipment Calibration
11
3.2.17 Cassette Image Plate Condition & Interplate
Sensitivity Variation (CR only)
11
3.2.18 Maintenance and Fault Logging
11
3.2.19 Infection Control of Breast Imaging Equipment11
7
4 Medical Physics Testing and Equipment
Performance
11 8
4.1 Introduction
11
4.2 Acceptance and Equipment Upgrade only
Procedure Recommendations
11
4.2.1 Focal Spot Size
11
4.2.2 Leakage Radiation
11
4.2.3 Transmission Through Breast Support
11
4.2.4 Missed Tissue at Chest Wall
12
4.2.5 Plate Fogging (CR only))
12
4.2.6 Modulation Transfer Function
12
4.2.7 Threshold Contrast Visibility
12
4.2.8 Spatial Linearity and Geometric Distortion 12
4.2.9 Distance Calliper Accuracy
12
4.2.10 Monitor Installation and Viewing Conditions 13
4.3 Annual Test Procedure Recommendations
13
4.3.1 Mammography Unit Assembly Evaluation 13
4.3.2 Collimation and Alignment Assessment
14
4.3.3 System Resolution / MTF
14
4.3.4 Automatic Exposure Control System
Performance Assessment / Signal Difference to
Noise Ratio
14
4.3.5 Image Uniformity and Artefact Evaluation 16
4.3.6 Image Quality Evaluation
16
4.3.7 Ghost Image Evaluation
16
4.3.8 System Linearity & Noise Analysis
17
4.3.9 kVp Performance (optional)
17
4.3.10 Beam Quality or Half Value Layer
17
4.3.11 Mean Glandular Dose
17
4.3.12 Exposure Time
18
4.3.13 Viewbox Luminance and Room Illuminance
(Hardcopy only)
18
4.3.14 Monitor Luminance and Viewing Conditions 18
4.3.15 Printer (Hardcopy)
19
4.3.16 Exposure Indicator Calibration & Image
Fading (CR systems only)
19
5 Biopsy testing: Facility procedures
5.1 Introduction
5.2 Procedure Recommendations
5.2.1 Stereotactic Accuracy Confirmation
5.2.2 Image Quality Evaluation
5.2.3 Mechanical Inspection

5.2.4 Repeat Analysis


5.2.5 Image Receptor Homogeneity
5.2.6 AEC Calibration Test (Technique Chart
Adequacy)

20
20
20

Biopsy testing: Medical Physics Tests

21

6.1 Introduction
6.2 Acceptance and Equipment Upgrade only
Procedure Recommendations
6.3 Annual Test Procedure Recommendations
6.3.1 Mammography Unit Assembly Evaluation
6.3.2 Collimation and Alignment Assessment
6.3.3 Automatic Exposure Control System
Performance Assessment / SDNR
6.3.4 Image Uniformity and Artefact Evaluation
6.3.5 Image Quality Evaluation
6.3.6 Mean Glandular dose
6.3.7 Localisation accuracy

21

Acknowledgments

22

Appendices

23

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21
22
22
22
22
22

Appendix 1a

Summary of Recommendations for


Facility QC Procedures for DR units 23

Appendix 1b

Summary of Recommendations for


Facility QC Procedures for CR Units 28

Appendix 2

Summary of Recommendations for


Medical Physics Testing only at
Acceptance or Equipment Upgrade

34

Appendix 3a

Summary of Recommendations for


Medical Physics Annual Testing of DR
Units
35

Appendix 3b

Summary of Recommendations for


Medical Physics Annual Testing of CR
Units
38

Appendix 6

Summary of criteria in terms of CR


exposure indicators

9 References

44
45

Introduction

1.1
Background
In 2001 the ACPSEM published a position paper entitled
Recommendations for a mammography quality assurance
program1 which has formed the basis for quality
assurance testing of mammographic equipment used for
both mammographic screening and diagnosis. These
recommendations have been adopted in Australia and
New Zealand by the Royal Australian and New Zealand
College of Radiologists and BreastScreen Australia and
19 incorporated into their respective mammographic
documents2,3.
19
20
Since that time, digital mammographic units have been
20
introduced into Australia and New Zealand and it has
20
20 been recognised that these units, utilizing varying
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technologies, cannot be adequately assessed by the
current quality assurance recommendations. A review of
overseas experience with digital mammography quality
assurance reveals a diverse set of situations.
Mammographic units marketed in the USA use company
specific protocols individually approved by the FDA,
although currently the American College of Radiology
(ACR) has a project to develop a generic set of
recommended quality assurance (QA) tests for digital
mammography4 and the Digital Mammography Imaging
Screening Trial (DMIST) that has been reported5-7. The
European community on the other hand have developed a
generic set of recommendations for implementation by
member states8,9. At this early stage of Australian and
New Zealand experience in digital mammographic
systems it was thought appropriate to adopt where
possible ACR test recommendations, however these have
been cross referenced to similar European Union test
recommendations where possible and in some cases tests
have been supplemented by the European Union protocol
requirements. Recently, the International Atomic Energy
Agency (IAEA) has also published a QA document for
use by member states62.
1.2
Scope of this Document
This paper has been written as a companion document to
the 2001 position paper. It is not the intent of this
document to alter any recommendations for screen-film
mammographic systems previously described. Many tests
used for digital mammographic systems are shared with
screen-film systems and, while a brief description of the
appropriate test is given below, the reader may wish to
refer back to the 2001 paper for a fuller discussion for
particular tests.
The paper is intended to provide:
(a) A brief introduction to the types of mammography
units described as full field digital mammography
(FFDM) units and those used for specimen biopsy.
(b) An overview of the role of the Medical Physicist in
mammography QA at acceptance, annual and regular
quality control (QC) testing.
(c) Recommendations for imaging system related QC
procedures to be performed by facility staff, which
are consistent with those recently prescribed by the
Royal Australian and New Zealand College of
Radiology (RANZCR)61.
This latter document
should be consulted for the detailed procedures
necessary when performing some of these tests.
(d) Recommendations for performance evaluation of
mammography imaging systems typically performed
by the Medical Physicist. One section of the
document discusses specific acceptance and
equipment upgrade tests, normally not repeated
annually, as well as annual tests that are performed at
acceptance and then as a part of routine testing.
(e) Recommendations for quality assurance testing of
stereotactic breast biopsy units.
It must be appreciated that the challenges of digital
imaging, and particularly those of mammography, are the
subject of intense research and development with many
bodies searching for a commonality of test procedures.

Every attempt has been made in this paper to assess these


developments, as they become available. However this
paper recommends testing that is currently achievable and
acceptable within the Australasian context, while
supporting future test principles, which may be more
useful with the advances in software, image phantoms and
a consensus of methodologies.

Digital Mammography Equipment

2.1

Full Field Digital Mammographic (FFDM)


Units
The term FFDM is intended to apply to any
mammographic unit producing images in digital format
with an image receptor capable of imaging a field size
comparable to that of current screen-film systems, that is,
18 cm x 24 cm and preferably 24 cm x 30 cm. It
specifically excludes film digitisers and obviously does
not include the small field of view digital biopsy units.
These latter are considered as a separate entity and are
discussed in section 2.2. As of 2012 there remain four
detector technologies available in the market place10,
which may satisfy the description of being a FFDM unit.
They are Computed Radiography (CR), indirect flat panel
arrays using CsI:Tl as the active detector material, direct
flat panel arrays using a-Se as the detector, and scanning
photon counting systems based on a silicon detector. All
of the solutions are characterised by having a high
dynamic range with the benefits of excellent low contrast
detectability when compared with screen-film but this
comes at the expense of reduced limiting spatial
resolution.
Each of these technologies, and the emerging concept of
digital breast tomosynthesis (DBT), which is showing
encouraging results in clinical trials, will be reviewed
briefly. It is also worth mentioning that contrast enhanced
mammography and dedicated CT mammography
technologies are also being developed but they have not
yet reached a mature enough stage to need addressing in a
quality assurance program.
2.1.1
Computed Radiography (CR)
Computed Radiography (CR) technology can be
considered as an intermediate step from a screen-film
system to a flat panel technology. The CR technology
involves the use of phosphor plate cassettes which can be
used on any suitable mammographic Bucky and
associated x-ray system. In this way the CR system can
stand alone and can be introduced to complement
existing X-ray units, thus providing a less expensive
method of achieving digital images. However such an
approach retains many of the disadvantages of screen-film
systems with no increase in patient throughput and the
lack of integration between the image receptor and x-ray
system that can be a vital part of flat panel arrays.
The physical principles of CR technology are well
established11. In the context of FFDM, it should be made
clear that the CR plates and readers commonly
encountered in radiology departments are not adequate for
mammography purposes as they suffer from relatively
poor spatial resolution, primarily because of the lateral
diffusion of laser light in the body of the phosphor. At
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the time of writing this revision a number of CR units
have been approved by the FDA in the United States for
mammographic use. Of particular note is the unit from
Fuji Medical Systems Tokyo, Japan, which utilises an
improved readout system achieved by the collection of
stimulated light emissions from both sides of the plate
(dual side read CR as illustrated schematically in Figure
1).
The published results of an evaluation of
mammographic detectors12 demonstrates that dual side
read devices have overcome some of the inherent X-ray
absorption and light collection efficiency limitations seen
in conventional CR systems with improvements in low
frequency detective quantum efficiency (DQE) of 40%.
More recently, other manufacturers have developed CR
systems based on needle phosphor technology and these
units seem to have improved performance compared with
their predecessors63,64. Nevertheless, field testing has
established that in order to achieve acceptable image
quality, CR systems operate at significantly higher doses
compared with the digital solutions described in
subsequent sections and referred to collectively as DR
systems75. It is therefore the view of the ACPSEM that
only DR technology should be approved for future
purchases of equipment for screening mammography in
Australia and New Zealand and existing CR systems
should be progressively replaced. Notwithstanding this
advice, tests on CR units are outlined below and have
been written to be as generic as possible.
Light guide
& PM-Tube

thin-film transistor (TFT) switches and turned into digital


data using an Analogue to Digital Converter (ADC).
Ideally, the magnitude of the digital signal is directly
proportional to the X-ray intensity absorbed by the CsI:Tl
scintillator directly above the del. Del sizes are typically
100 m, which implies a detector limiting spatial
resolution of approximately 5 lp/mm.
X-rays
Pixel
matrix

Line
driver

Amplifier,
multiplexer
& ADC

Photo diode

Exploded view
of pixel element
showing switch

Contacts

Figure 2. The indirect flat panel detector based on a CsIscintillator with a-Si switching diodes and TFT-read out.
The X-rays absorbed in the CsI layer are first converted
to light which is then converted to a charge signal by the
photo-diodes and ultimately digitised.

Scanning
laser

2.1.3
Direct Flat Panel Detectors
An alternative flat panel detector is that based on a-Se
technology. This detector type utilises an a-Se array with
a typical thickness of 250 m to detect the X-rays directly
and then converts them into a charge pulse map that is
collected by a set of simple a-Si electrode pads. Since the
charge is swept out of the a-Se volume under the
influence of a high voltage (see Figure 3) lateral diffusion
effects are minimal and the technology is claimed, at least
in principle, to be superior in terms of its DQE and spatial

Mirror

Stimulated
emissions

CsI
scintillator

Imaging
plate

X-rays

Top
electrode
Light guide
& PM-Tube

Figure 1. Dual Sided CR reading. The Imaging plate


(phosphor) has a transparent protective coating on both
sides allowing the laser stimulated emissions to be
collected by the optics for subsequent digitisation.

a-Se layer
Charge
collection
electrode

2.1.2
Indirect Flat Panel Detectors
General Electric (General Electric Healthcare,
Milwaukee, WI, USA), has developed digital flat panel
detectors based on amorphous silicon (a-Si) coupled to a
scintillator such as CsI:Tl (see Figure 2). The detection
process can be considered in three distinct steps. First,
the CsI scintillator absorbs the X-rays and converts them
to light, just as it does in the input phosphor of an image
intensifier. Then a low noise a-Si photodiode array
absorbs the light and converts it to an electronic charge
signal. Each photodiode corresponds to a single del in the
image matrix. The charge at each del is read out using

Signal
out
Gate
pulse

Charge storage
capacitor

TFT

Figure 3. The direct flat panel detector utilising a-Se as


the X-ray absorber. When a voltage is applied across the
a-Se layer, the charges produced are collected by the
electrodes and digitised.
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resolution to the previously mentioned detectors. The del
size ranges between 50 m and 85 m implying an
approximate detector limiting spatial resolution of
between 10 lp/mm and 6 lp/mm, respectively. While this
detector could be used with a standard focused linear grid
the Hologic unit (Hologic, Bedford, MA, USA) uses a
unique hexagonal grid. This grid must complete an
integral number of cycles during an exposure and this
constraint is a determining factor in automatic exposure
parameter selection including tube current.

counting with energy discrimination allowing rejection of


scattered photons and electronic noise (i.e. individual Xrays are detected as single events and a decision made to
either accept or reject them on the basis of their energy).
There are no intermediate conversion steps as X-ray
energy is converted directly to charge in a crystal silicon
detector, which is operated on edge to give excellent
absorption efficiency (>90%) with a high fill factor (i.e.
all detector material area is utilised). The image is made
up of 4800 x 5200 dels covering a FOV of 24 x 26 cm2
each of size 50 m implying a nominal 10 lp/mm detector
resolution. A key to the success of the unit is pre and post
breast collimation with 28 thin fan beams producing an
essentially zero scatter environment. Each fan beam, as
defined by the pre breast collimator, has dimensions of 24
cm x 0.065 mm. As a result of this design grids are not
required and doses are typically less than a half of those
obtained with screen film mammography.

2.1.4
Scanning Photon Counting Systems
A Swedish Company (Sectra Medical Systems,
Linkoping, Sweden) has marketed a novel system called
the MicroDose. The unit is based on multiple scanning
slit technology15 (see Figure 4), which shares a degree of
commonality with scanning CCD technology developed
by Fischer Imaging (Fischer Imaging, Northglen, CO,
USA) but which is no longer commercially available.
However, it has the additional concept of single photon
Side View

Front View

Pre-collimator

X-ray Tube

X-ray fan
beam

Compression
plate

Mechanical
link

Gantry
movement
Pre-collimator
Breast
Post-collimator
Si strip detectors

Post-collimator

Si strip detectors

Figure 4. Sectra Microdose Multi-slit scanning unit. Narrow slit collimators define fan beams that image part of the
breast. Post breast collimators further reduce the impact of scatter. The multi-slit device moves across the breast ensuring
that all breast tissue is imaged. The crystal-Si detector elements are also unique in that they collect and record the energy
from discrete X-rays.
2.1.5
Digital Breast Tomosynthesis (DBT)
One of the disadvantages of conventional 2D projection
mammography is that overlying tissue, particularly if it is
dense, can mask the appearance of suspicious lesions.
Accordingly, most manufacturers are either investing in
or have already produced technology capable of
performing DBT. Figure 5 provides a schematic of what
the process entails. In essence a number of low dose
images are acquired at different angles around the breast.
As the figure illustrates, the relative positions of details in
the image changes with projection angle. Even with a
limited number of views sufficient data is produced to
allow the generation of a 3D data set from which images
of thin slices of breast tissue may be reconstructed. This
minimises the loss of structural information associated
with 2D imaging and offers hope that fewer cancers will
be missed, most particularly in dense breasts.

Figure 5. The principle of DBT. The X-ray tube is


rotated about the breast and several low dose images, in
this case seven, are acquired. The relative positions of
the fiducial marker and the lesion within the breast
change in the image with angle. From these images a 3D
data set is obtained from which images of thin slices of
breast tissue may be reconstructed.

At this early stage of its development DBT is not regarded


as a screening methodology and may be used as an
adjunct to conventional mammography in those cases
requiring further workup. However, at least one
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manufacturer (Hologic, Bedford, MA, USA) is
developing software that will allow the generation of
synthetic 2D projection images from the 3D data set used
to produce the tomosynthetic images. This would replace
the need for conventional projection mammography to be
performed in addition to DBT.

to ensure that the dose to the breast is not excessive and


that the signal difference to noise ratio (SDNR)2 is
acceptable. This has implications for the type of QC
measurements that are undertaken with digital
mammography units (see sections 3.2.14 and 4.3.4).
Further, the sophistication of the AEC varies between unit
types. All systems determine the technique factors, with
the exception of the mAs (and possibly the kVp), from
lookup tables in response to the breast thickness as
indicated by the breast paddle position. Some systems
then utilise information direct from the image detector
obtained with a short trial exposure to modify the
technique factors based on an estimate of breast density.
The exposure (mAs) is terminated when the integrated
detector signal at the selected region reaches an
acceptable level. In all cases the position of the breast
paddle is critical to the AEC process emphasising the
importance of correct breast thickness measurement.
Innovative methods to utilise detector signals in AEC
determination for scanning technologies are currently
under consideration 18,19. In the Sectra scanning system,
for example, information from the leading detector line is
utilised to adjust the scan velocity during the scan18.

The ACPSEM acknowledges that QC of DBT units is in


its formative stages at this point in time. Thus, the
ACPSEM recommends that site and medical physicist
testing be conducted as recommended by the relevant
manufacturer to confirm that their specifications are being
met.
2.1.6
Digital Image Display Systems
Advances in image display have been just as critical as
have image detectors for digital mammography to achieve
clinical acceptability. The work of the AAPM is
universally accepted as being pre-eminent in this field16,17.
Displays currently utilise either cathode ray tubes (CRT),
albeit rarely now, or liquid crystal displays (LCD) and are
classified as either primary or secondary. The ACPSEM
recommends that all future tenders for primary and
secondary workstations specifically exclude CRT
displays. Primary display systems are those used for the
interpretation of medical images (in this case
mammographic) by the radiologist, while secondary
systems are those used by other medical personnel for
quality control purposes or after the interpretation report
is rendered17. It is essential that primary display units
have the capacity to display 5 Mega pixels (5 MP) of
information in order to limit the extent to which the
interpreting radiologists has to utilise the zoom and
roam functionality workstations offer, as this is tedious
and time consuming. Further in the case of image storage
or transfer a lossless compression should be used to allow
full image quality for image interpretation. Experience
has also indicated that the monitors used on the
acquisition device must also be of relatively high quality
in order to ensure that movement artefact is not missed by
radiographers when performing basic QC on the images.
Accordingly, the ACPSEM recommends that such
monitors be at least 3 MP, and should preferably be gray
scale rather than colour monitors with sufficient bit depth
to demonstrate the ramps in the TG18-QC test pattern
continuously. This means that both the primary and
secondary displays (specifically the one on the acquisition
workstation) must conform to the DICOM 3.14 Grayscale
Standard Display Function (GSDF). Conformance to the
GSDF ensures that the perception of contrast is the same
in all regions of an image, irrespective of the background
luminance. It should also ensure that the image looks the
same on all calibrated monitors.

2.2

System
Types
Included
as
Biopsy
Mammographic Units
Stereotactic breast biopsy units are mammographic units,
or attachments to mammographic units, that allow
identified sections of the breast to be sampled for
diagnostic or treatment purposes. Film based systems
cause long waiting times for patients while film
processing takes place and have been superseded by
digital biopsy systems. These systems can be either
dedicated biopsy units (usually with prone tables) or
attachment units (usually upright with the patient seated)
connected to existing mammographic units. In the case of
dedicated units the full range of tests described will need
to be undertaken, however for mammographic units with
attachments, many of the prescribed tests will already be
completed in routine testing of either a screen-film or
digital mammographic unit.
The detectors used have a limited coverage (typically 5
cm x 5 cm) and for the attachment units may either be a
sub section of the digital detector used in FFDM
applications, or form part of the attachment unit itself. In
this latter case, and in the case of dedicated prone units,
the detectors commonly use a single CCD chip
technology. At least two different implementations of the
technology are available. Siemens Medical Solutions
now market a unit (previously developed by Fischer
Imaging) using tapered fibre optics to couple light from a
Kodak Min R screen to the CCD array. Lorad Medical
Systems (a subsidiary of Hologic) uses conventional
lenses in their design. In both instances, the CCD array is
1024 x 1024 (note that a 512 matrix can also be selected
and this is more commonly used clinically doses can be
quite high using the 1024 array) and both systems have

2.1.7
Automatic Exposure Control (AEC)
As noted by Pisano and Yaffe10, digital mammography
image brightness and contrast are controlled by adjusting
the window and level controls of the image display
workstation quite independently of image acquisition.
Thus, the AEC is not required for this purpose but rather

SDNR was previously referred to as the contrast to noise ratio


(CNR). SDNR terminology is now preferred62,74

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Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


policy which specifies tri phosphor phosphorescent tubes
or equivalent and ensures that all light boxes have tubes
of the same colour and intensity. To be effective this may
require light box tubes to be replaced simultaneously.

demonstrated spatial resolution of between 5 and 10


lp/mm. Diagnosis may be made from soft copy or from
hard copy.
2.3
The Role of the Medical Physicist
Acceptance testing gives the purchaser of complex
equipment the opportunity to determine if equipment
installed performs to the standard specified. Digital
equipment allows instantaneous feedback on the
radiographic process. Information such as patient dose
must be verified along with the optimisation of image
quality, the correct configuration of processing algorithms
and display devices and the correct transfer of digital data.

3.2.2
Image Plate Erasure (CR only)
CR Image plates are sensitive to scattered and naturally
occurring radiation sources and if left unused for long
periods of time will store energy absorbed from these
sources. It is recommended that all CR image plates be
subjected to erasure procedures on a daily basis as per
manufacturers instructions. Fuji Medical Systems refer
to this as a secondary erasure but they also require a
primary erasure to be performed on a weekly basis.

The tests described below form a minimum set of tests


that should be conducted annually. These tests should be
performed according to displayed technique factors that
are used clinically. As well as providing a report to
indicate corrective action by a qualified service person,
the medical physicist should also make recommendations
that may improve image quality and/or reduce patient
dose. The facility or radiographer tests should also be
reviewed, with assistance given when test procedures are
not clearly understood by radiographic staff.

3.2.3

Full Field Artefact Evaluation & System Check


(DR systems only)
The standard test block of PMMA covering the complete
image receptor should be imaged using clinically relevant
technique factors and the image viewed on the acquisition
monitor. Zoom and roam should be used to check for
possible detector faults such as dead dels. The test should
be undertaken on a daily basis61,62. This test is designed
to detect changes in the performance of the entire imaging
chain including the X-ray system and the detector. If hard
copy interpretation is undertaken then a printed image
should be produced

Facility Quality Control Procedures

3.1
Introduction
As in screen/film mammography, facility quality control
procedures for digital mammography systems are
essential for ensuring production of high quality
mammography images. Failure to implement adequate
QC procedures has proven to reduce the image quality
significantly which may result in lower detection rates for
breast cancers. The effectiveness of the QC program is
reliant on the correct performance of the QC procedures,
results being charted/recorded and compared with
previous results or set limits and appropriate corrective
action being taken when needed 2,3,61 The routine control
procedures to be performed by facility staff are listed in
Appendices 1a and 1b and further discussion of the
testing is provided in the following section.

The mean pixel value in the image is measured using a 4


cm2 ROI positioned centrally along the long axis of image
receptor and 6 cm in from the chest wall. The mean pixel
value and the mAs should be within 10% of the baseline
value (provided a consistent choice of kVp, anode and
filter is used). The for presentation or processed image
should be used to make this measurement3.
Additionally, the for presentation image should be
examined using clinically relevant window/level settings
and observed to be free from clinically significant:
Blotches or regions of altered noise appearance.
Grid lines or breast support structures.
Bright or dark pixels.
Dust artefacts mimicking calcifications
Stitching or registration artefacts.
Any processing artefacts (if applicable).

3.2
Procedure Recommendations
3.2.1
Viewing Conditions
Viewing conditions are extremely critical when
presenting high quality mammography images for
interpretation. The ambient light levels and reflections
can affect the quality of displayed mammography images
(hard copy and soft copy) through artefacts and loss of
image quality including loss of perceived contrast 5,7,17,22.
The ACPSEM recommends that a visual inspection of
ambient lighting conditions be made daily61 by facility
staff to ensure conformance with the acceptable viewing
condition configuration determined by the medical
physicist at acceptance testing. Ideally, third monitors,
which may be used for providing worklists and other
associated tasks on some diagnostic workstations, should
be blanked out to keep light to acceptable levels. When
assessing viewing conditions for viewboxes (hard copy
interpretation) a visual inspection of uniformity of
brightness and confirmation of the presence and operation
of masking must also be made. To be effective this
requires clinical departments to have a tube replacement

3.2.4
Monitor QC
In digital mammography the monitor is the primary
means of interpretation and as such provides the vital link
between the image acquisition system and the image
reader.
These display devices are susceptible to
maladjustment and drift and often their QC is
overlooked7. Monitors used for interpretation and those
attached to the acquisition workstations must be tested
regularly to ensure that displayed images are a true
representation of the for presentation image sent from
the acquisition system. It is recommended that all

Unfortunately, with the Sectra L30 system the placement of


ROIs with a processed image is not possible so this procedure
must be undertaken with a raw image.

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monitors used for acquisition or interpretation have the
TG 18-QC test pattern displayed on them each week7,9,17.
Evaluation by the same person on a routine basis is
recommended. The ACPSEM recommends that the
provision by the vendor of the TG18-QC test pattern,
rather than the older SMPTE test pattern, be included in
the tender process and the pattern should be preloaded on
the mammography system prior to acceptance testing.
The TG 18-QC test pattern image displayed at a scale of
1:1 must be evaluated to ensure that:
Borders are visible,
lines are straight,
squares appear square,
the ramp bars should appear continuous without
any contour lines,
there is no smearing or bleeding at black-white
transitions,
all corner patches are visible,
squares of different shades from black to white
are distinct,
all high contrast resolution patterns and at least
two low contrast patterns are visible in all four
corners and the centre
the 5% and 95% pixel value squares are clearly
visible,
the pattern is centred in the active area,
no disturbing artefacts are visible and
the number of letters visible in the phrase
Quality Control for the dark, mid-gray and
light renditions is at least eleven.

156) for image quality evaluation because of its current


widespread availability and use in screen film
mammography1. The for presentation or processed
image may be assessed, using the zoom and modest
adjustments of the window/level functions available in
order to visualise the specks and fibres. The masses
should be scored without the need for zooming.
As with its use in screen film mammography there are a
number of key procedural elements which are relevant in
acquiring the phantom image:
Maintain light contact between the compression
paddle and the phantom surface.
Position the phantom consistently. Centred
along the long axis of the image receptor and
flush with the chest wall is recommended.
Use a consistent selection of clinically relevant
kVp and target/filter combinations.
Select the density control setting in current
clinical use (if applicable).
Use a consistent AEC detector position where
this is manually selected
For CR use a designated test cassette and
imaging plate that is in routine clinical use. To
avoid variations in image quality caused by
image fading it is suggested that the plate be read
at a fixed time delay (say 30 seconds) after
irradiation.
If hardcopy images are used for reporting or if
this image is to be used for a measure of signal
difference to noise ratio (SDNR) (see section
3.2.9), the acrylic contrast disc must also be
used. It is preferable to place this on, rather than
under, the paddle to minimise the chance of
causing damage to the latter.

The TG 18-QC test pattern image must be evaluated


under optimal viewing conditions as specified in section
3.2.1 and typical viewing distances should be employed
when assessing resolution test patterns. Additional test
patterns should be viewed as prescribed by the monitor
manufacturers QC program

Apart from the evaluation of the phantom image the


technique factors associated with the image acquisition
should be recorded and it is suggested that a control chart
be employed for this purpose. Previously, the ACPSEM
had recommended that for DR systems the mean pixel
value and signal to noise ratio (SNR) in a reproducible
region of interest (ROI) of standard size of approximately
100 mm2 should be measured using the workstation tools.
This requirement has now been supplanted by the
requirement to measure the SDNR as described below in
section 3.2.9).

3.2.5
Monitor/Viewbox Cleaning
The monitor/viewbox is the final device used in
presenting high quality mammography images for
interpretation. The cleanliness of the monitor/viewbox
can have an effect on the quality of the mammography
images that are displayed. The ACPSEM recommends
weekly cleaning of monitors and viewboxes to ensure
they are free of dust, fingerprints and other marks that
might interfere with image interpretation.
The
manufacturers specific instructions should be adhered to
when choosing cleaning agents.

For CR units, the SDNR is not easily obtained, due to the


absence of ROI tools, in some units, but the exposure
indicator, or a parameter related to it (see below), should
be recorded. If reporting is performed from hard copy the
optical density in a reproducible part of the phantom
image (e.g. the centre) should be measured.

3.2.6
Printer Area Cleanliness
Where printers are used to produce images for
interpretation it is important to ensure dust-related
artefacts are not introduced on to the images. It is
recommended that weekly cleaning of areas where film
magazines are loaded and film is printed be undertaken, in
order to maintain a clean, dust free environment.

When visually scoring the details present in the phantom


images care should be taken to ensure consistency of
viewing conditions and also that these conditions reflect
those used to read clinical mammograms. This applies to
both soft and hard copy where applicable. Ideally, image
quality scoring should be undertaken by the same person,
if possible. With the ACR Accreditation phantom the

3.2.7
Image Quality Evaluation
Although there are a number of test objects available for
this purpose the ACPSEM currently recommends
retaining the ACR Accreditation phantom (e.g. the RMI
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ACPSEM now believes that, using the RANZCR scoring
system1 a score of at least 5 fibres, 3.5 speck groups and 4
masses must be achieved in the digitally acquired image.
This is a tighter requirement than that currently in place
for screen film mammography. Ideally, 4 speck groups
should be visualised but field testing has established that
significant variations in scoring of specks can arise when
different ACR phantom units are utilised, this variation is
attributable to manufacturing tolerances and aging of the
wax insert test object.

SDNR for a single phantom thickness remains


approximately constant over time and ideally this
measurement should be undertaken on those systems
where it is performed semi-automatically by the system
software. The test should be carried out weekly in
accordance with the manufacturer specific methodology
as described in the recently amended RANZCR QA
document61 or using the ACR phantom with PMMA
contrast disc on the paddle. The basic requirement is that
the SDNR vary from the baseline value by less than
20%.

Ideally, image quality should be scored on the modality


used for reading clinical images i.e. the reporting
monitors or the printed copy if hardcopy is used for
reporting. However, this may not always be practicable,
especially if images are sent to a separate site for reading.
In this case, it is acceptable to score the phantom on the
acquisition work station but it is best practice if the image
is also scored on a reporting monitor at least once a month
to check that PACS causes no image deterioration.
Furthermore, there is significant variation in the
resolution of acquisition monitors supplied by each
vendor. If the ACR phantom score (particularly speck
groups) is not acceptable on the acquisition monitor, it
should be verified that it is satisfactory on the reporting
monitors.

3.2.10 Printer QC
In order to produce high quality mammography images
for interpretation the printer used must be monitored to
ensure it is functioning optimally. This should involve
higher resolution and maximum density settings than are
usually found in non mammographic situations.
Monitoring for changes in geometric distortion, contrast
visibility, resolution, optical density range and artefacts
will ensure that high quality images are produced. The
TG 18-QC, rather than superseded SMPTE, test
pattern16,17 (Figure 6) is used widely for examining these
parameters7.

When evaluating the performance of CR systems, the


significance of variations in the exposure indicator
requires some comment as the specification of an
acceptable tolerance depends on the equipment
manufacturer and, in some instances, on the choice of
algorithm used in the image acquisition. The basic
premise is that the air kerma (dose) to the plate should not
change with time by greater than 10%.
The
equivalences in terms of the exposure indicator are given
in Appendix 6.
Detector Calibration Flat Field Test (DR
Systems only)
This test ensures that the detector is properly calibrated,
the image is uniform over the entire field of view, and that
a high and consistent level of image quality is maintained.
The test should be carried out in accordance with the
manufacturers methodology61. The outcome of the test is
a simple pass or fail.
3.2.8

Figure 6 TG18-QC test pattern.

3.2.9

Signal Difference to Noise Ratio (DR Systems


only)
When screen-film was used, one of the important
parameters for image quality was contrast. However,
digital detectors have a much wider dynamic range and
therefore wider exposure latitude. Combined with image
processing and the ability to adjust the contrast and
brightness of the image, this means that the important
parameter is not simply contrast but a new parameter
called the signal difference to noise ratio (SDNR). The
ACPSEM considers that the way to optimise a digital
mammography system is to achieve established minimum
target SDNR values as a function of breast thickness.
Medical physicist annual testing will confirm if this is the
case (see section 4.3.4). However, the ACPSEM now
believes an important routine test is to ensure that the

It is recommended that the TG 18-QC test pattern be


printed monthly on each dry printer (daily or as used for
wet printers), to confirm that:
Borders are visible,
lines are straight,
all corner patches are visible,
squares of different shades from black to white
are distinct,
all high contrast resolution patterns are visible in
all four corners and the centre,
the 5% and 95% pixel value squares are clearly
visible,
no disturbing artefacts are visible,

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any ROI differs from that for the central ROIs by more
than 15%. For CR units the evaluation should be
restricted to a consideration of three ROIs placed in a line
parallel to the chest wall and 20 mm from it to avoid
issues associated with the heel effect. The mean pixel
values for the three ROIs should not differ by more than
10%.

the number of letters visible in the phrase


Quality Control for the dark, mid-gray and
light renditions is at least eleven.

Also measurements must be made of the mid density


(MD) and density difference (DD) to ensure they are
within 0.15 OD of their baseline values. Additionally
the Base + Fog (B+F) should be within 0.03 OD, and
maximum density (Dmax) within 0.10 OD, of their
respective baseline values. Further, the B+F should be
0.25 OD and Dmax 3.4 OD. The TG 18-QC test pattern
image must be evaluated under optimal viewing
conditions as specified in section 3.2.1. Charts plotting
the temporal variation of the above parameters will
facilitate the observation of significant trends.

For all systems the maximum variation in the mean pixel


value of the central ROI between successive QC
measurements should be less than 10%.
Meeting the above specification may be problematical if
the PMMA block is not uniform. If this is found to be the
case then in order to exclude failure due to such non
uniformities a second image should be obtained with the
block rotated 180 between exposures. The average of
the mean pixel values in each of the comparable ROIs is
then used in the analysis.

3.2.11

Mechanical Inspection & Breast Thickness


Indication
As in screen/film mammography the facility staff must
perform an overall mechanical inspection of the digital
mammography system and associated components5. The
inspection should be carried out monthly to ensure there
are no hazardous, inoperative, out of alignment or
improperly operating items on the system. As part of this
process, particular care must be taken to ensure that the
machine indicated compressed breast thickness remains
within tolerance, that is within 5 mm of the actual
thickness at the manufacturers specified compression and
specified paddle (see also section 2.1.7).

If the software required for these calculations is not


available, as is the case for some CR units, a visual
inspection of the image using a narrow window may be
all that can be done.
3.2.14 AEC Calibration Test
The AEC calibration testing involves obtaining images of
PMMA blocks of thickness 2 cm, 4 cm and 6 cm in
contact and magnification mode, if applicable. Ideally,
the blocks should completely cover the detector (as this
also enables artefact evaluation), but if not, they should be
positioned in a consistent manner (e.g. flush with the
chest wall). Clinically relevant AEC exposure factors
should be used, as displayed on the technique chart. In
some systems, the chosen thicknesses of PMMA above
may correspond to one or more switching points in the
AEC selection procedure for determining the technique
factors. This may make for difficulties in achieving
consistency and the problem can be exacerbated if
inconsistent application of compression leads to variations
in the machine displayed thickness. For CR units the
designated test cassette should be employed and the
exposure indicator recorded.

3.2.12 Repeat Analysis


The overall procedure will be as per existing
mammography recommendations1, however if reject
images cannot be digitally stored it is recommended that a
log be kept for the examination reject analysis period.
However some new categories for repeat causes may need
to be created for digital mammography (e.g. software
failures, blank images, non appearance of images on the
acquisition station, although an exposure was made,
etc.)4.
3.2.13 Image Receptor Homogeneity
Whilst there is general agreement that the evaluation of
image receptor homogeneity should be undertaken
routinely there are some differences as to the
methodology that might be employed and the standards of
performance that might be expected4,9. In some cases the
test methodology may be dictated by the manufacturers
software which may provide a totally automated measure
of homogeneity. In all cases the image of a standard
PMMA test block covering the entire image receptor is
obtained.
The PMMA block must be free of
imperfections, dust and dirt. It is recommended for DR
units that five ROIs, each of approximately 100 mm 2, are
specified; one centrally located and the other four placed
near the corners of the image with their outer boundaries
20 mm from the image margins. The analysis should be
performed on for processing (unprocessed or raw)
image data, if possible, using the manufacturers
recommended calibration technique factors, and simply
requires the extraction of mean pixel values from each of
the five ROIs and determining if the mean pixel value for

While the EU guidelines9 for image assessment uses


calculation of signal to noise ratios (SNRs), in practice
difficulties arise because of the need for pixel offsets4 to
be applied and the lack of available software.
Accordingly, the recommended set of measurements
proposed is:
For DR systems the mean pixel value in a
specified ROI in each image is measured using a
4 cm2 ROI positioned centrally along the long
axis of image receptor and 6 cm in from the chest
wall9.
For CR systems the exposure indicator is
recorded. To avoid variations in the exposure

Some manufacturers add a constant number to the value of the


signal assigned to each pixel. This is referred to as the pixel
offset value.

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indicator caused by image fading it is suggested
that the plate be read at a fixed time delay (say
30 seconds) after irradiation.

Medical Physics Testing and Equipment


Performance

4.1
Introduction
Both acceptance and annual testing are essential for
digital mammographic units, the major difference being
the extent of the testing being undertaken. Acceptance
testing should be significantly more thorough. Digital
mammographic units may be configured and operated in a
wide range of exposure settings. It is the view of the
ACPSEM that units be tested in the manner they are used
clinically. It is therefore essential that the Medical
Physicist determines what the clinical configuration and
usage of the unit is before testing begins. Of particular
concern is determining the mode of diagnostic reporting
that is in use; that is, if the image is presented on a
monitor or on a film/viewbox. If the mode is ambiguous
then both display systems must perform to the required
standard.

It is recommended for DR units that the mean pixel value


be within 10% of the baseline value for the respective
PMMA thickness. The unprocessed or raw image must
be used to make this measurement.
Similarly for CR units, the basic requirement is that the
average dose to the plate for each of the three thicknesses
of PMMA be within 10% of the baseline value for that
thickness. Appendix 6 should be consulted to see what
this means in terms of the manufacturer specific exposure
indices.
Additionally, the for presentation image should be
examined using clinically relevant window/level settings
and observed to be free from clinically significant:
Blotches or regions of altered noise appearance.
Grid lines or breast support structures.
Bright or dark pixels.
Dust artefacts mimicking calcifications
Stitching or registration artefacts.
Any processing artefacts (if applicable)).

4.2

Acceptance and Equipment Upgrade only


Procedure Recommendations
The acceptance and equipment upgrade procedures to be
performed by the medical physicist are listed in Appendix
2 and further discussion of the testing is provided in the
following sections.

3.2.15 Compression
The requirements are as per existing mammography
recommendations1
but
with
the
measurement
methodology simplified to the extent that the site need
only confirm that the mammography unit digital readout
of the compression force meets these specifications.

4.2.1
Focal Spot Size
System resolution is dictated by both the focal spot size
and image receptor resolution. In a non digital system the
limiting resolution, as measured by a line pair test object,
is a good indicator of system resolution. This is not the
case in a digital system where the receptor resolution is
usually limited by the receptor detector element (del) size.
It is however still essential that the system Modulation
Transfer Function (MTF) not be compromised by an
inappropriately large focal spot size. The ACPSEM
therefore recommends, in line with the European
recommendations9, that the focal spot of the system be
determined at acceptance. This may be achieved through
a limiting resolution measurement on film or CR imaging
plate as described previously1,9 although this will become
increasingly difficult with the demise of printed film.
Thus, in line with the International Electrotechnical
Commission (IEC) principles of accepting certified
documentation in lieu of the results of physical
measurements at accreditation 20,21, provision of
documentation demonstrating IEC certification verifying
the focal spot size21,26 is acceptable for this test.

3.2.16 Test Equipment Calibration


As per existing mammography recommendations1
3.2.17

Cassette Image Plate Condition & Interplate


Sensitivity Variation (CR only)
Apart from the visual inspection of images of a uniform
test object such as 4 cm of PMMA for artefacts, this test
is analogous to the uniformity of screen speed test of
screen-film mammography conducted semi-annually.
The QC test cassette/plate is irradiated using clinical
relevant AEC settings and processed on three separate
occasions to confirm repeatability of the X-ray tube
output. To avoid variations in the exposure indicator, or
its surrogate, caused by image fading each plate should be
read at a fixed time delay (say 30 seconds) after
irradiation. All other plates are then irradiated in turn and
the exposure indicator of each plate is recorded. The
basic specification is that the dose to any image plate
should differ from the mean for that size by less than
5%. Appendix 6 should be consulted to see what this
means in terms of the manufacturer specific exposure
indices.

4.2.2
Leakage Radiation
The ACPSEM recommends1 that testing be performed at
acceptance and tube change to meet the minimum leakage
requirements specified in the Australian and New Zealand
standard27. Further the ACPSEM recommends that the
leakage measured at 30 cm from the focal spot using 30
kVp shall be 0.01 mGy/100 mAs28.

3.2.18 Maintenance and Fault Logging


As per existing mammography recommendations1.

4.2.3
Transmission Through Breast Support
The ACPSEM1 supports the specification in the relevant
Australian and New Zealand standard27 that the maximum
permitted air kerma transmitted through the breast support
be 1 Gy per exposure. Acceptable methods for testing

3.2.19 Infection Control of Breast Imaging Equipment


Before each examination as per existing mammography
recommendations1.
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(27 m thick), stainless steel35 (80 m thick) or brass with
tungsten or lead 34. The test object should be placed on
the image receptor so that it makes an angle to the pixel
rows or columns of between 1o and 3o. An image should
be acquired using the same technique factors that would
be relevant for the ACR Accreditation phantom except
that the mAs should be increased by a factor of between
two and four. The DICOM image is then processed with
software (see references above for details) to give the
MTF. The test procedure should be repeated with the test
object raised above the image receptor by 40 mm.

for compliance with this specification, that remain valid


for CR based systems, are partially outlined in AS/NZS
3200.1.3:1996 (p. 26)27. For DR systems the requirement
is waived unless specifically required by State or National
Regulatory bodies.
4.2.4
Missed Tissue at Chest Wall
This test is specified as an acceptance only test, however
it is a simple test that can be incorporated into the image
quality phantom test. The aim is to determine the amount
of tissue not imaged between the edge of the breast
support and the imaged area. This may be achieved with
the use of a phantom (the ACR recommend a 40 mm
thick PMMA block with a top and bottom vertical flange
at breast wall side) with distance markers at fixed
distances from the chest wall on the breast support side.
Alternatively, some units indicate the image field area on
the breast support which, after determining the accuracy
of this indication, allows vernier callipers to be used to
measure the distance to the edge of the breast support. If
the acquisition workstation has image measurement
capabilities one simple method involves taping a coin so
that it is flush with the breast support, performing a low
dose exposure and then measuring the extent to which the
coin is not fully imaged. The ACPSEM supports the limit
of 5 mm as the maximum amount of missed tissue in
contact mode.
For magnification mammography a
slightly weaker limit of 7 mm is acceptable but not
desirable.

4.2.7
Threshold Contrast Visibility
The threshold contrast detail phantom test uses the
CDMAM 3.4 phantom. This phantom has been adopted
in Europe as the basis of image quality assessment and
relies on the theory that digital images are ultimately
quantum noise limited. This premise has been challenged
recently by work that illustrates that clinical projection
images are in fact limited by structured noise from the
parenchymal pattern of tissue36,37. The reality of this is
clearly demonstrated with the good low contrast visibility
achievable through DBT. The current utilisation of the
CDMAM phantom has also recently been investigated
with the difficulties in the scoring of the phantom
demonstrated38,39. It is believed that automatic reading of
the phantoms may alleviate the problems experienced
with this phantom although such software72 may
introduce inherent scoring biases.

4.2.5
Plate Fogging (CR only))
This test assures that the storage locations for CR
cassettes are sufficiently shielded to prevent fogging
artefacts. One cassette is selected and erased. A coin is
then taped to the cassette which is left in the storage area
with the coin facing the tube for a significant time, for
example the complete acceptance testing period. The
cassette is then read using minimal screen processing and
no post processing. Some units may allow quantitative
evaluations in terms of their exposure indicator being
within pre-determined specifications. In any event, the
image of the coin should not be visible in the image even
when a narrow window is used for viewing purposes.

The ACPSEM therefore does not advocate the use of the


CDMAM phantom for quality control, however it
suggests that selected large centres continue to monitor
and investigate the use of this phantom as it a very
sensitive test of noise limited systems.
4.2.8
Spatial Linearity and Geometric Distortion
A convenient way to observe any spatial non-linearity and
geometric distortion is to image a film/screen contact
mesh pattern with light compression. The mesh may need
to be placed asymmetrically on the imaging device in
order to avoid Moire effects in the image arising from
sampling frequency issues. The image is viewed in
magnified mode using magnify and roam tools and any
distortion is readily evident, although the assessment is
somewhat subjective.

4.2.6
Modulation Transfer Function
The modulation transfer function (MTF) is recognised as
the best indicator of equipment system resolution. It can
be measured with either of two methods. The first uses
either the Fourier transform of a point spread function,
line spread or edge response function (ERF)29. The
second approach uses a bar pattern phantom and the
application of the Coltman transform30. A variation of the
latter methodology has been described by Droege and
Morin31 and is currently favoured in the IEC draft
acceptance testing document32. Recently the use of the
ERF has been generally discussed in the literature for
MTF measurement in mammography5,33,34 and advocated
by another IEC draft document35. The test requires a
square test object with sides of at least 50 mm long. It
should be mounted on a backing plate, large enough to
cover the entire detector. The ACR suggest 0.8 mm of
aluminium is suitable for this purpose. The test object
may be made of a variety of materials such as Niobium 33

4.2.9
Distance Calliper Accuracy
Confirmation of the system distance callipers, and hence
pixel size by implication, may be undertaken by imaging
steel rulers of known length placed parallel to and at 90
to the chest wall. The rulers should be placed in direct
contact with either the breast support or a CR cassette,
depending on the indicated circumstances.
Direct
measurement in the image using the measurement tools
should confirm the distance accuracy to better than 2%.
In some instances, a small correction for magnification
effects may be required to correct the distances measured
in the images to the manufacturers reference plane. For
example, with the Hologic Selenia Dimensions 2D
(Hologic, Bedford, MA, USA) the reference plane is 22.5
mm above the breast support. Thus, in this instance,
where the source to breast support distance is 675 mm, a
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multiplicative correction factor of 1.034 should be
applied.
Ideally, distance measurements should be
undertaken at the reporting workstation in contact mode
and in each clinically used magnification mode to
confirm that there are no issues with the transfer of
dimensions to PACS as such problems have been noted in
the literature66. When that is not possible the images
should be evaluated at the acquisition workstation or
exported to another workstation and evaluated with a
DICOM viewer.

example are seen, the position of the display device is not


appropriate. If patterns such as an identification badge on
a white shirt etc. are seen, the ambient illumination in the
room should be reduced.
The effect of diffusely reflected light on image contrast
may be observed by alternately viewing the low-contrast
patterns in the TG18-AD test pattern in near total
darkness and in normal ambient lighting, determining the
threshold of visibility in each case. A dark cloth placed
over both the display device and the viewer may be
helpful for establishing near total darkness. The pattern
should be examined from a viewing distance of 30 cm.
The threshold of visibility for low-contrast patterns in the
TG18-AD test pattern should not be different when
viewed in total darkness and when viewed in ambient
lighting conditions. If the ambient lighting renders the
dark-threshold not observable, the ambient illuminance
on the display surface may be causing excess contrast
reduction, and the room ambient lighting needs to be
reduced.

4.2.10 Monitor Installation and Viewing Conditions


Special attention should be paid to the monitor installation
and viewing conditions for display systems.
The
ACPSEM believes it is essential that monitors used for
primary assessment of the mammographic image be
monochrome and capable of displaying 5 MPs. As
previously noted, those used on the acquisition device for
QC should be capable of displaying at least 3 MP. The
luminance range should be measured with an
appropriately calibrated (or traceable) photometer. The
ratio of the maximum to minimum luminance must be
greater than 250. The maximum luminance of two or
more diagnostic monitors on a workstation must be
matched to within 5%. The maximum luminance must be
>450 cd/m2 (relaxed to >240 cd/m2 for CRT displays)43
for a primary display device and > 100 cd/m2 for a
secondary display device used for QC (e.g. acquisition
monitor).

4.3
Annual Test Procedure Recommendations
The annual test procedures to be performed by medical
physicist are listed in Appendices 3a and 3b and further
discussion of the testing is provided in the following
sections.
4.3.1
Mammography Unit Assembly Evaluation
The mammography X-ray unit should be inspected to
confirm correct function of column rotation, vertical
drives, locks and indicators and to identify any
miscellaneous safety related issues (e.g. jam risk, system
stability, loose cabling etc.) as described elsewhere1,2.
Evaluation of thickness display accuracy should be
included using PMMA thicknesses ranging from 2 to 8
cm under a compression force of 70 to 90 N. Care should
be taken to avoid any scratching of either the compression
paddle or the breast support. Some manufacturers advise
the use of semi circular or triangular PMMA blocks.
These shapes have the advantage of applying a more
realistic pressure pattern to the paddle but will affect the
measurement performance of the paddle, as will the use of
spring loaded or flexible paddles. A tolerance of 5 mm
for the thickness display accuracy is recommended for
conventional paddles.

Monitor tests are commonly achieved through the


viewing of test patterns that can be obtained directly from
the
AAPM
TG-18
website
http://deckard.duhs.duke.edu/~samei/tg18.htm. However
they may be supplied or installed by the monitor supplier
and are specific to the monitors used. The use of non
matched test patterns results in aliasing which prevents
the proper assessment of monitor devices. In many cases
the patterns are already incorporated into manufacturer
specific QC programs with daily, weekly or monthly
testing frequencies specified. At acceptance, all tests
should be performed in accordance with the AAPM
recommendations16,17 Special attention is needed in a
Picture Archiving and Communication System (PACS) or
when the workstation and display devices are not from the
same vendor as the primary digital imaging system. Tests
unique to commissioning of a new monitor might include
noise (TG18-AFC), veiling glare (TG18-GV, GVN,
GVs), chromaticity, electronic cross talk (LCD only)
(TG18-LPH-02) pixel defects (LCD only) (TG18-UN10
and TG18-UN80) and display noise (TG18-AFC) as well
as tests detailed in section 4.3.14.

The clinical operational settings should be clearly


displayed on a technique chart adjacent to the console as
is the case for screen-film mammography1. This should
include magnification and implant settings as
appropriate.

To reduce image glare the walls of the reporting room


should be painted with a non-reflecting material and
should be in a dedicated area to ensure appropriate
ambient lighting. To assess specular reflection observe
the display when turned off, from typical positions for
interpretation under normal ambient. At a distance of
about 30 to 60 cm within an angular view of 15 no
specular reflections, such as high contrast objects
including patterns on the viewers clothing should be
seen. If light from a film illuminator or window for

The displayed image information from the DICOM


header24 of any randomly selected patient image should
be verified for the correct display of relevant parameters
such as institution name, patient name, patient ID number,
projection and technique factors, acquisition time and
date. This should be also checked after software
upgrades. Unfortunately, when CR is used as the image
processing device the DICOM tags for the technique
factors will not be populated unless a Protocol Bridge
(Livingston Products Inc., Wheeling, Illinois, USA) is
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installed.
For
recommended.

screening centres this is highly

mammographic equipment. If this is not the case the


MTF can be obtained using an exported DICOM image of
a suitable test object using third party software.

4.3.2
Collimation and Alignment Assessment
The importance of maximum X-ray coverage of the
mammographic film has been covered elsewhere1. This
requirement may not be as essential with true digital
receptors where any unexposed sections of the image
receptor are commonly processed digitally to create a
fully dark background to the mammographic image.
However, when assessing a digital mammography system
it remains important to ensure that the entire image
receptor can be irradiated. When assessing a system
using CR as the image receptor account should be taken
of the variation in CR plate position in the cassette and
any latitude in the position of the cassette in the image
receptor holder.

Notwithstanding the above, if the MTF cannot be


measured easily the limiting resolution should be
measured using a resolution pattern placed on 40 mm of
PMMA. In either case, measurements should be
undertaken in both contact and magnification mode.
4.3.4

Automatic
Exposure
Control
System
Performance Assessment / Signal Difference to
Noise Ratio
The AEC is perhaps the most important component of the
digital mammography system as it controls the dose and
image quality of the system. Some of the AEC tests, such
as reproducibility, backup timer and/or security cut-out
require no real change from the screen-film situation 1,
while the concept of thickness compensation is essentially
superseded by measures of dose and image quality as a
function of object thickness. The case of CR is an
exception, where the host mammographic unit requires
calibration to facilitate appropriate exposure settings for
different object thicknesses. The function of the density
control (if applicable) is also different in that the range of
mAs values provided should be much greater than that for
screen-film mammography as the main requirement now
is to change the level of image noise. Specifically, the
density control should be capable of changing the mAs
from the value used normally by -25% to +50%.

In previous versions of the position paper a formal


requirement was placed on the alignment between the Xray and light fields. The ACPSEM believes this is no
longer necessary. One requirement that is retained is the
proviso that the X-ray field extend to the edge of the
image receptor at the chest wall but not exceed it by more
than 2% of the SID. This requirement can be established
most simply with a fluorescent screen.
Finally, correct alignment of the front edge of the
compression paddle is important. If the outer paddle edge
is positioned more than one percent beyond the image
receptor edge on the chest wall margin the amount of
breast tissue missed by the paddle position will exceed
that allowed by the missing tissue test. Alternatively, if
the paddle edge falls within the image area, breast tissue
in the image will be obscured. A very simple method for
determining the position of the paddle with respect to
image receptor is to physically measure the overhang of
the paddle with respect to the breast support with a ruler
and add this measurement to the missing tissue value (see
section 4.2.4). When checking the alignment of flexible
paddles, particular care must be exercised as the
alignment will vary significantly depending on the
amount of compression applied. It is suggested that little
or no compression force be applied or the paddle be
positioned parallel to the breast support.

At acceptance testing, the DR equipment vendor must


provide the manufacturers recommended target pixel
values and allowable tolerance for a range of PMMA
absorber thicknesses. In some systems, the AEC is
designed to maintain an essentially constant MPV over
the thickness range, in which case a single target value is
appropriate.
When testing CR systems, to ensure constancy and to
avoid variations in the exposure indicator, or its surrogate,
caused by image fading it is suggested that the plate be
read at a fixed time delay (say 30 seconds) after
irradiation.
For systems that produce film images for diagnosis the
optical density should comply with the standards for film
screen mammography.

4.3.3
System Resolution / MTF
While the system resolution of a screen film system is
typically constrained by both the focal spot size and the
image receptor resolution, digital system limiting
resolution in mammography is effectively constrained by
the del size (see section 4.2.1). Thus, the use of a limiting
resolution test pattern in the digital case typically yields
only partial resolution information whereas measurement
of the MTF will give more complete information about
system performance. Thus, the preferred technique,
which remains optional, is to measure the system MTF.
The use of a metal straight edge, placed on top of 40 mm
of PMMA, with appropriate software is recommended.
Alternative test objects, such as bar pattern objects, with
appropriate software may be used.
As digital
mammography QC becomes standardised it is expected
that test tools and software will be provided with the

Signal Difference to Noise Ratio (SDNR)


The assessment of image quality is primarily achieved
with the measurement of the SDNR. This measurement
requires a uniform phantom with a test object of slightly
varying attenuation. Many manufacturers provide a
phantom for this measurement, which may consist of a
PMMA sheet with either a hole test object, or uniform
button. However, perhaps the simplest is a test object
consisting of an aluminium foil of thickness 0.2 mm (such
as is used for HVL measurement)8. Images of this test
object are made under AEC with 2, 4 and 6 cm
thicknesses of PMMA. The technique factors should be
recorded as it is important that these are the same or very
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freeware image analysis programs24,,25,65.
It had
previously been suggested that image data should be
linearised first with respect to dose before the SDNR is
calculated. Recent experience suggests that provided the
contrast object is relatively thin, the SDNR calculated
from the unprocessed, non-linearised CR data is a very
good approximation to the true SDNR calculated with
linearised data. Note that in contact mode, the target
SDNR values in the range 2 cm to 6 cm PMMA must be
achieved by the AEC without recourse to the operator
intervening in the selection of the density control setting.
However, if a host mammographic unit allows a change in
density control with thickness to be pre-programmed then
this is an acceptable means to achieve the required
outcome. On the other hand, in magnification mode
operator adjustment of the density control to achieve the
acceptable SDNR values, whilst not desirable, is allowed.
Thus, if testing establishes that the density control must
be adjusted manually as the thickness changes in
magnification mode then the medical physicist must
notify the site that a technique chart for magnification
mode reflecting this fact must be posted on the operators
console.

similar factors are utilised in the determination of the


mean glandular dose as described in section 4.3.11 5.
In each for processing or raw image the mean pixel
value (MPV) and standard deviation (SD), respectively
are calculated for a ROI located in a uniform part of the
phantom (PVb, SDb) and in an area where the Al foil is
located (PVAl, SDAl). Both ROIs should be centred on a
line parallel to and 6 cm (3 cm for magnification
images) from the chest wall to minimise the impact of the
heel effect and ideally the image pixel values should be
linearised with respect to dose before the SDNR as
defined below is calculated. The SDNR is defined as9:

SDNR

PVb PVAl

[ SD 2b SD 2Al / 2]

The European provisional specification9 requires that the


measured SDNR be at least 110%, 100% and 90% of the
minimum acceptable SDNR with 4 cm PMMA
(designated as SDNRaccept) with 2 cm, 4 cm and 6 cm of
PMMA as a test object, respectively. For each model of
mammography system, the value of SDNRaccept is unique
and has been established from experience in Europe by
reference to imaging performance with the CDMAM test
object mentioned in section 4.2.7. The table below
provides a list of digital mammography units with
recommended values of the parameter SDNRaccept for use
in contact mammography.

Table 1 DR and CR manufacture specific values of SDNRaccept


with 4 cm PMMA

Recent experience suggests that these values are also


universally applicable in magnification mode with DR
units but not with CR units. Accordingly, the required
specification for the SDNR for 6 cm PMMA imaged in
magnification mode with CR is relaxed but it must still be
at least 65% of SDNRaccept.
Some further comment is required about the process of
establishing compliance with the acceptable limits.
Testing should initially be undertaken using the AEC
settings normally used clinically by the site in question.
If the medical physicist finds non-compliance then they
must undertake further testing to establish AEC settings
that will provide compliance. Any recommended changes
must be clearly communicated to the site in their report.
In most CR systems it may be difficult to extract
meaningful statistics relating to ROIs because of the
inadequacies of workstation software.
Under these
circumstances, it will be necessary to export
uncompressed, unprocessed, DICOM images to a USB
stick or compact disc for subsequent analysis with

Manufacturer

Model

SDNRaccept

Fuji

Amulet

5.6

General Electric

2000D
DS
Essential

8.1
8.1
11.5

Hologic

Selenia (Mo or W anode)


Selenia Dimensions 2D
Selenia Dimensions 3D

4.35
4.4
2.3*

Philips

MammoDiagnost DR

4.0

Sectra

L30 (v 8.3 software)


D40

5.1*
3.3

Siemens

Novation (Mo or W anode)


Inspiration

4.8
4.0

Agfa

CR 85-X with MM 3.0 plate


DX-M with HM5.0 plate

11.1
9.35*

Konica

Regius 190 with RP-6M plates


Regius 190 with RP-7M plates
Regius 190 with CP-1M plates

10.4
8.0
6.0

Fuji

Profect CS with HR-BD plates

8.9

Carestream

DirectView with EHR-M2


plates
DirectView with EHR M3
plates
DirectView with SNP-M1
plates

7.8

Philips

Eleva Cosima X with Fuji HRBD plates

10.2
7.0*
8.9

*Provisional values
5

Reference 8 specifies that the Al test object should be 4 cm2.


Since then, European practice has suggested that a much
smaller piece of Al (e.g. 10 mm 10 mm) is more appropriate to
minimise issues to do with the heel effect and the AEC being
impacted on by the presence of the Al foil. With this in mind, the
ROIs used in the analysis should now be ~ 0.25 cm2. Some
flexibility must be expected when positioning the Al test object
when assessing the SDNR from magnification images.

Finally, it is important to note that the acceptable SDNR


values referred to in Table 1 must be obtained within the
dose constraints discussed in section 4.3.11 and also
within the exposure time limits specified for imaging of 6
cm PMMA in section 4.3.12.
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4.3.5
Image Uniformity and Artefact Evaluation
Image uniformity includes a measure of (i) spatial, (ii)
temporal uniformity of image detector or image plate
response to radiation and, in the case of CR technology,
(iii) the uniformity of response of each cassette/image
plate within the clinical set of utilised plates. This last
requirement is analogous to the screen cassette uniformity
test conducted with screen film as the image receptor 1.
The procedure for all three uniformity measures is
essentially similar with a standard test PMMA block of
thickness 40 mm covering the entire image receptor being
exposed under the same AEC conditions with which the
unit has been calibrated. If a mammography DR system
is utilised by the clinical site for assessment then both
contact and magnification modes should be evaluated.

Image artefacts can interfere with the detection of cancers


and also be the source of false positive image
interpretations.
Usually images obtained whilst testing image receptor
uniformity with PMMA test objects may be suitable for
identifying and assisting in the elimination of some
artefacts. Images should be free of blotches or regions of
altered noise patterns, free from grid lines or breast
support structures and bright or dark pixels.
Further, artefacts unique to digital detectors may arise.
Specifically, detector element failures can occur. The
manufacturers should provide access to a dead pixel
map which indicates which del values are not based on
their own reading. This should be inspected by the
medical physicist at each visit and compared with earlier
maps. No specific limits apply at this point in time but
future requirements are likely to be based on limiting the
number of defective dels in a defined area to a maximum
percentage.
In the interim, the manufacturers
specification should apply.

To assess the spatial uniformity qualitatively the image is


simply viewed with a display window width of 10% of
the mean pixel value. Preferably, uniformity can be
assessed quantitatively for DR units by measuring the
mean pixel value (with pixel offset value subtracted). The
ROI size recommended in the European protocol 9 is 100
mm2. Apart from the central one, all ROIs should be
placed about 20 mm from the image margins. The
maximum deviation in the mean pixel value for each ROI
should be less than 10% of the mean pixel value for the
central ROI. To exclude failure due to non uniformity of
the block, the block can be rotated 180 degrees and a
repeat measure taken. With CR units the heel effect is not
usually corrected for and the procedure may be simplified
slightly by requiring that the mean pixel value and SNR
be evaluated using just three ROIs placed on a line
approximately 20 mm from and parallel to the chest wall.
The mean pixel values for the three ROIs should not
differ by more than 10%43. Should the left or right SNR
values drop significantly below the central SNR, it is an
indication of possible damage to the CR plate(s) and it
may be appropriate to consider replacement of the
plate(s). With new plates the SNR variation should be
<15%.

4.3.6
Image Quality Evaluation
The ACPSEM recommends the use of the ACR
Accreditation phantom (e.g. the RMI 156 or equivalent)
for base line image quality evaluation but with the
additional proviso that, using the RANZCR scoring
system1, a score of at least 5 fibres, 3.5 speck groups and
4 masses must be achieved in the digitally acquired image
at a mean glandular dose (MGD) of 2.0 mGy for that
phantom. Ideally, 4 speck groups should be visualised but
field testing has established that significant variations in
scoring of specks can arise when different ACR phantom
units are utilised, This variation is attributable to
manufacturing tolerances and aging of the wax insert test
object.
4.3.7
Ghost Image Evaluation
A ghost image represents the remnants of a previous
image arising either as a result of the detector memory
(DR systems) or incomplete erasure (CR systems). Both
qualitative and quantitative (preferred) evaluations may
be undertaken depending on the capability of the
acquisition workstation.

Temporal uniformity or system response stability is


assessed by comparing the SNR from the central ROI
with that from previous measurements. A maximum
deviation of less than 10% in SNR is required.
For CR cassettes it is also necessary to assure that the
image response does not vary between cassette/image
plates. In this case the image post processing should be
turned off as much as possible. The basic criteria for inter
cassette/image plate uniformity is 5% in terms of mAs
or dose to the plate. A comparison of the exposure
indicator, or its surrogate, for all plates is appropriate as
discussed in the technologists section (see section 3.2.17
and Appendix 6).

A 4 cm thick PMMA block is positioned such that half


the detector or CR cassette is covered and an exposure is
made using typical exposure factors under manual control
(e.g. 28 kVp, 50 mAs). This creates the ghost image. For
DR systems a second exposure is taken, after a delay of
about a minute, at the same clinical settings but with the
PMMA block completely covering the detector. For CR
systems the cassette is erased using the normal readout
cycle before the second exposure is undertaken with the
geometry described in the previous sentence.

If more than one cassette size is utilised in the practice


then the tolerances (see Appendix 6) should apply to each
size separately with the further proviso that the difference
in the average dose to the imaging plate for the two sizes
is less than 20%. Appendix 6 should be consulted to see
what this means in terms of the manufacturer specific
exposure indices.

The ghost image evaluation involves determining the


mean pixel value (PVi) in two ROIs in the second image.
The two ROIs are placed equidistant from the boundary
defining where the PMMA and no PMMA regions existed
in acquiring the ghost image. The noise (SD) is also
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measured in the ROI that corresponds to the region that
would have been under the PMMA in the ghost image
formation. The Ghost Image Factor is then defined by:

4.3.9
kVp Performance (optional)
Previously, the ACPSEM had recommended that kVp
performance be evaluated on an annual basis. This is no
longer felt to be necessary once it has been established at
acceptance testing.
However, since it remains a
regulatory requirement in some jurisdictions it is retained
as an optional test.

Ghost Image Factor = |(PV1 PV2)|/SD


and should be less than 2.0.
4.3.8
System Linearity & Noise Analysis
The response of DR systems to air kerma variations
should be linear. To test this, the for processing
(unprocessed or raw) images of a 40 mm PMMA block
covering at least the central part of the detector should be
acquired under manual control at a clinically relevant kVp
and target/filter combination (i.e., those selected under
AEC for 40mm PMMA). The range of mAs values
selected should cover the clinically useful range (e.g. 5 to
300 mAs). The air kerma (K) is measured by placing a
dosimeter on or next to the PMMA and approximately 60
mm from the chest wall in the irradiated field in a position
that will not influence the subsequent image
measurements. Images are viewed and a ROI is drawn
centrally along the long axis and approximately 60 mm
from the chest wall. The mean pixel value (with pixel
offset value subsequently subtracted) and standard
deviation (SD) are recorded.

A minimum of three manually selected exposures is


recommended to assess the reproducibility of kVp. These
exposures should be made using a kVp and target/filter
combination that is in routine clinical use. The COV
should not exceed 0.02 for kVp reproducibility.
The kVp accuracy should be measured across the entire
range of kVps used clinically. The measured kVp should
be within 5% of the specified value.
4.3.10 Beam Quality or Half Value Layer
An accurate measurement of half value layer (HVL) is
required to allow estimation of the MGD. At a routine
evaluation the HVL (with compression paddle in the
beam) need only be measured for target/filter and kVp
settings related to MGD calculations. At acceptance, the
evaluation should be extended to include at least one kVp
at all possible target/filter combinations as this may be
required for subsequent dose audits.

For DR systems a plot of mean pixel value (MPV) against


the K is drawn and linearity tested by noting the square of
the correlation coefficient (R2).
A reasonable
specification is to require that this plot should have R2
>0.994,9. In a change from previous versions of this paper
the ACPSEM now recommends that some limited
analysis of image noise is appropriate. This is done by
plotting the SD2 against the MPV and fitting a quadratic
function of the form:

The ACPSEM1 requirements for the HVL with the paddle


in the beam are as follows:
[(kVp/100) + 0.03] HVL< [(kVp/100) +C]where
C
= 0.12 mm Al for Mo/Mo
= 0.19 mm Al for Mo/Rh
= 0.22 mm Al for Rh/Rh
= 0.30 mm Al for W/Rh
= 0.32 mm Al for W/Ag
= 0.25 mm Al for W/Al.

SD2 = a1 + a2 MPV + a3 MPV2


where a1, a2, and a3 represent the relative contributions of
electronic,
quantum
and
structure
noise,
respectively63,64,74.75. It should be noted that where
manufacturers include a PV offset in their images then
this offset must first be subtracted from the measured
pixel values before the above plot is undertaken. The R2
value from this fit should be > 0.99 and the fitted
parameters should not change significantly from one test
to the next.

If the unit is used for biopsy purposes with an open


paddle, at acceptance, the HVL should be measured at 28
kV for all available target/filter combinations with the
paddle removed from the beam. HVLs measured under
these conditions must comply with the requirements of
AS/NZS 4184.3.2:199844.
4.3.11 Mean Glandular Dose
The measurement of Mean Glandular Dose (MGD) is
essential to the assessment of the performance of the
imaging system as a whole. The measurement is used to
ensure that the system complies with dose limits specified
by accrediting and/or regulatory bodies, and to allow
comparisons between systems. The measurement of
MGD should ideally be undertaken for a range of breast
thicknesses as, in many cases, the unit displays an MGD
for each procedure, and also because the dose value is
crucial to determining whether the AEC of a digital
system is optimised.

Similar test procedures apply for CR systems except that


the response to air kerma variations depends on the
system. In all cases the exposure indicator is recorded for
each image, which must be acquired with the same
cassette on each occasion. The extraction of mean pixel
values and standard deviations may be problematic at
best. In any event, it is simpler to confirm linearity by
examining the dependence of the exposure indicator on
the ESAK. The appropriate plot (see Appendix 6) of
exposure indicator against the ESAK should have an R2
value of >0.99. There remains no specific requirement to
perform any noise analysis, as discussed above, on CR
systems although this is an option that remains at the
discretion of the medical physicist.

As noted previously the MGD is calculated from the


incident air kerma to a breast phantom together with
suitable conversion factors that vary with beam quality,
breast thickness and breast glandularity1,45. A number of
studies have evaluated breast glanularity46-52 with the UK
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Sechopoulos et. al67,68 have published a dosimetric
methodology for DBT that can be used in conjunction
with the standard American College of Radiology
dosimetric techniques55-57. A similar approach has been
developed by Dance et al69 for use with European
dosimetry models. Currently dose algorithms are also
utilised by manufacturers of DBT units, however the basis
of calculation is not always known70.
Recent
measurements and simulation appear to indicate that the
added radiation dose from the use of DBT instead of
FFDM systems varies with breast thickness and
glandularity with a range of increases from about 10% to
75% for a 50% glandular breast71.

adopting the studies of Young et al and Beckett et al as a


basis for their dosimetry protocol53. There is reasonable
agreement between most of the studies in the breast
thickness range of 3 to 6 cm thick, however at thicknesses
above 6 cm the UK glandularity values are considerably
lower than the results from Germany50, the US46,48 and
Australia49. The European protocol has adopted the UK
dosimetry model and has further converted thicknesses of
PMMA into breast equivalent thickness and
corresponding glandularity8,53.
The ACPSEM believes that for simplicity the MGD
should be assumed to be for a 50% glandular, 50%
adipose breast unless otherwise stated45. Further, that
dose indicators displayed for mammographic exposures
should be verified, as far as possible, over a range of
thicknesses for both contact and magnification modes as
appropriate. Such verification may be done with breast
phantom material simulating 50% glandular, 50% adipose
material, but with a 5 mm layer of adipose material on the
top and bottom of the phantom. However, for ease of
testing it is preferred that PMMA be utilised. Published
data54 converting PMMA block thicknesses to equivalent
50% glandular, 50% adipose breast material thickness
may then be utilised to calculate the MGD. Specifically,
the relationship between PMMA and breast tissue
equivalent thickness may be expressed by the equation:

4.3.12 Exposure Time


In the earlier position paper59 it had been a requirement
that the radiation output rate be measured to confirm that
it was sufficiently high to keep clinical exposure times
within a reasonable range. The requirement to have short
exposure times remains important for both contact and
magnification digital imaging. However, rather than
measuring the output rate, it is now felt that a sufficient
requirement is to measure the exposure time6, or infer it
by observing the required mAs, under AEC operation
using clinically relevant technique factors (kVp,
anode/filter combination etc.) to image 6 cm of PMMA
and dividing by the known tube current, specified in the
technical manual. The technique factors employed in this
test must be consistent with those used in the assessment
of the SDNR and the MGD (see sections 4.3.4 and
4.3.11). It is suggested that the exposure time required,
for fine and broad focus modes of operation, be less than
3.5 seconds and two seconds, respectively.
This
provision is waived for the scanning slot technologies.

Breast thickness (mm) = 1.047 * PMMA thickness (mm)


+ 1.78.
Care must be taken to correct any measured incident
kerma values to the height of the breast equivalent
thickness, not to the PMMA entrance level. The
ACPSEM recommends use of the procedures and
conversion tables published by Wu et al 55,56 or their
analytical equivalent57. It should be noted that the
European protocol uses the dose formulation of Dance
and a correction factor for geometry is built into the
conversion factors used for the specified granularities
assigned to various breast thicknesses58.

4.3.13

Viewbox Luminance and Room Illuminance


(Hardcopy only)
As in screen film mammography every effort must be
made to keep ambient lighting as low as possible as
outlined elsewhere.
4.3.14 Monitor Luminance and Viewing Conditions
It is essential to check the monitor installation in detail
with the use of the TG18 test pattern series9,16,17,62 prior to
conducting any image quality assessments of X-ray
images as has been mentioned previously (section 3.2.4).
All relevant test patterns17 should be viewed and if even
subtle departures from the expected appearance are seen,
further investigation with the appropriate technician is
required. This may reveal set up errors or deficiencies.
Special attention is needed in a Picture Archiving and
Communication System (PACS) or when the workstation
and display devices are not from the same vendor as the
primary digital imaging system.

The following dose limits apply. For 20 mm and 60 mm


PMMA, the MGD must be less than 1 mGy and 4.5 mGy,
respectively. For the ACR Accreditation phantom the
MGD must be 2 mGy.
If measuring MGD for magnification mammography,
caution should be taken in applying the conversion factors
published for the contact geometry and the physicist is
referred to the work of Liu et al59.
Modern DR mammographic equipment records a value
for the mean glandular dose in a DICOM structure of each
mammographic image and this value is also displayed on
the acquisition workstation monitor and may be issued in
a structured dose report in future. The validity of such
values should be checked by the medical physicist for a
range of breast types and thicknesses. It is noted that
increasingly electronic dose related data is gathered for
dose information statements, therefore it is of importance
that the veracity of such information be established.

If the exposure time is to be measured directly then it should be


done using a manual exposure that matches the mAs needed for
the AEC controlled exposure. This avoids the inclusion of the
trial exposure which if included will give the impression of an
erroneously long exposure time.

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Ambient lighting conditions are more critical for monitor
viewing due to the lower luminance levels provided by
monitors. Any windows in the viewing room should be
covered to exclude daylight. Room lighting should be
indirect. Care should be taken that no direct illumination
from room lighting or other sources falls directly on a
monitor (including the acquisition monitor). The ambient
lighting should be measured and be less than 20 lux.

4.3.16

Exposure Indicator Calibration & Image


Fading (CR systems only)
The exposure indicator (EI) is used clinically by
radiographers as a guide to confirm that the image is
acceptable. Accordingly, the ACPSEM believes that the
EI calibration should be established on an annual basis.
Each manufacturer has its own procedure for confirming
the EI calibration and their methodology must be
followed closely. In essence the CR plate is irradiated
directly (i.e. out of Bucky) with a known dose and then
read out after a fixed time delay. Note that the
measurement should be undertaken at a dose relatively
close to the specified dose of 175 Gy and the EI then
normalised to this dose to confirm the calibration. The
accompanying Table 2 summarises the techniques used to
undertake the test and provides allowed tolerances.

Geometric distortion (CRT displays), contrast visibility


and display artefacts are tested using the TG18-QC test
pattern, while a range of test patterns can be used to check
image resolution. The screen should be cleaned before
assessment.
Luminance range should be measured with an
appropriately calibrated (or traceable) photometer. The
maximum luminance must be >450 cd/m2 (relaxed to
>240 cd/m2 for CRT)43 for a primary display device (used
for diagnosis) and > 100 cd/m2 for a secondary display
device used for QC. The maximum luminance of two or
more diagnostic monitors on a workstation must be
matched to within 5%. Further, it is important to ensure
that the monitors are closely matched in terms of the ratio
of the maximum to minimum luminance.

Table 2 Exposure Indicator Calibration Tolerances for a dose


to plate of 175 Gy using Mo/Mo spectrum

Luminance response should be measured to check


whether a display is calibrated to the DICOM Grayscale
Standard Display function (GSDF). Conformance with
the GSDF ensures the image will appear similar on
different viewing stations and on printed film. The test
patterns TG18-LN12-01 through to TG18-LN12-18 are
used to determine this function using a photometer43,73.
The TG18-QC pattern may also be used but each
grayscale square should be zoomed and centred.

Manufacturer

Exposure
Indicator

Calibration
conditions

EI value

Fading

Fuji,

S#

25 kVp, no
paddle,
readout time
10 min, use
QC Test /
sensitivity

12020

<12

Konica

S#

As per Fuji
but
use
Mammo Test
Phantom

12020

<12

Philips

S#

As per Fuji
but use Test
Sens
Hi
Matrix

12020

<12

Carestream

EI

28 kVp, 2
mm
Al,
readout time
5 min, Pattern
raw

2300100

<45

Agfa

SAL,
SAL log,
PVIlog16

28 kVp, 2
mm
Al,
readout time
105 sec, Flat
field

1130100
216001000
411001300

<60
<450
<600

Luminance uniformity should also be checked using test


patterns TG18-UNL10 and TG18-UNL80.
The
maximum deviation of a display device should be less
than 30% (Lmax-Lmin)/Lcentre<0.3).
4.3.15 Printer (Hardcopy)
The initial set up of the printer is critical and must be
examined closely to ensure correct installation. In
particular the laser spot used for scanning must be on the
lowest setting and the maximum optical density must be
at least 3.4. The full range of TG18 test patterns should
be printed from each workstation that services the printer
(usually at least the acquisition and reporting
workstations). Careful examination of these images may
reveal subtle errors in the printer set up or the transfer
look up tables.

It is also useful when performing the calibration test to


confirm the extent to which the EI changes with the time
delay between exposure and readout this is called
fading. Experience suggests that fading, which may be
defined as the absolute change in EI when the readout
time delay is changed from 1 minute to 5 minutes, should
be minimal and should the relevant value in the last
column of Table 2 be exceeded then the test should be
repeated with a different CR plate to confirm the
outcome. Plates exhibiting excessive fading should be
removed from service.

Test patterns are used to test geometrical distortion,


contrast visibility, printer artefacts, density response and
uniformity.
Conformance with the GSDF can be
determined by printing the TG18-PQC test pattern 9,16,17
and measuring the optical densities of the marked
regions73.

Biopsy testing: Facility procedures

5.1
Introduction
The tests for biopsy units discussed in this section are
based, in part, on the ACR 1999 manual60. It is also
assumed that film based units are no longer employed and
that CR technology is not used for biopsy procedures. As
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highlighted in the ACR manual a key issue when using
biopsy units is the establishment of technique charts,
whether an AEC is available or not. With digital
receptors inappropriate technique factors may lead to
either noisy images (due to inadequate x-ray intensity) or
saturated detector systems (due to excessive X-ray
intensity). The correct use of technique charts should
ensure minimal repeat rates arising from these causes.
Accordingly, the usefulness of the posted technique chart
should be reviewed at least semi-annually as part of the
site QC.

clumsy with small FOV units. Rather, the ACPSEM


recommends the use of the ACR mini digital
stereotactic phantom (e.g. the NA 18-250 or equivalent)
for image quality evaluation but with the additional
proviso that a score of at least 3 fibres, 3 speck groups
and 2.5 masses must be achieved in the digitally acquired
image using the RANZCR scoring system60. This is
equivalent to the standard used for FFDM and with ACR
requirements60. Note that if the RMI 156S phantom is
used, it is important to recognise that it contains one less
speck group and one less mass. Thus, an acceptable score
with the RMI 156S phantom is 3 fibres, 2 speck groups
and 1.5 masses. In other respects the procedure is similar
to that discussed in section 3.2.7.

5.2
Procedure Recommendations
Three different configurations of units may be
encountered in the field; (i) integrated, where the same
detector is used for mammography and biopsy use, (ii)
separate image receptor where an x-ray system common
to mammography but with a different image receptor
assembly is used, and (iii) stand alone where full testing
must be completed. As such, it must be anticipated that in
some cases little or no additional QC testing may be
required for biopsy units whilst in other instances
variations to the basic tests outlined in section 3 should be
expected. However, the following site QC tests:
Viewing Conditions (see section 3.2.1)
Artefact Evaluation (see section 3.2.3)
Monitor QC (see section 3.2.4)
Monitor/Viewbox Cleaning (see section 3.2.5)
Printer Area Cleanliness (see section 3.2.6)
Printer QC (see section 3.2.10)
Compression (see section 3.2.15)
Test Equipment Calibration (see section 3.2.16)
should mirror those discussed previously and
summarised in Appendices 1a and 4. Maintenance and
fault logging and infection control of breast imaging
equipment should be treated as per existing
mammography recommendations for screen-film units1.

5.2.3
Mechanical Inspection
In addition to the general inspection features carried out
on FFDM units it is recommended that the following
checks be undertaken:
The image receptor and compression plate
biopsy window is demonstrated to be free of
wobble
The vernier table drive and needle guide is rigid
and is demonstrated to be free of wobble
The localisation system zeroes coordinates
properly, and
The biopsy device is properly immobilised to
prevent recoil.
5.2.4
Repeat Analysis
The issues noted in section 3.2.12 apply but it should be
observed that the analysis should be performed semiannually and be based on a sample of at least 150 patients.
It should include all images for a patient procedure. A
repeat rate of <20% should be achieved 60.
5.2.5
Image Receptor Homogeneity
Of necessity, because of the small FOV some biopsy units
have, the procedure discussed in section 3.2.13 must be
modified slightly. It is suggested that the four ROIs
placed at the corners of the image be located
approximately 10 mm, rather than 20 mm, from the image
margins on units with a FOV of less than 100 mm square.
Some separate image receptor systems do not allow the
placement of ROIs on the image so that a visual
inspection using an appropriately adjusted level and
narrow window is all that may be possible.

Specific requirements or variations for other tests are


discussed briefly below.
5.2.1
Stereotactic Accuracy Confirmation
Localisation accuracy confirmation should be performed
prior to patient use on each day that the biopsy unit is
used. The ACPSEM recommends calibration in air as per
the ACR manual60 unless the manufacturer specifies an
alternative technique using a suitable localisation
phantom. The required accuracy, in air or using a suitable
localisation phantom, is that the indicated needle tip
coordinates be within 1 mm of the actual preset needle
position in each direction (horizontal, vertical and depth).

5.2.6

AEC Calibration Test (Technique Chart


Adequacy)
The procedure outlined in section 3.2.14 may be applied
in slightly modified form. Clinically relevant technique
factors should be used to obtain images of PMMA blocks
of thickness 2 cm, 4 cm and 6 cm. The technique factors
may be selected by the AEC, or from a technique chart or
from a combination of the two. The PMMA blocks
should be positioned in a consistent manner (e.g. flush
with the chest wall). The mean pixel value in a specified
ROI in each image is measured using a 4 cm 2 ROI
positioned centrally. The same specification as for FFDM
units applies. That is, it is recommended that the mean
pixel value be within 10% of the baseline value for the
respective PMMA thickness. Some separate image

If the biopsy unit fails this test possible sources of error


should be investigated. Possible causes could include a
wobbly needle guide, a bent needle, a gap between the
biopsy device and its holder, inappropriate needle type or
incorrect throw length data entered into the computer 60.
5.2.2
Image Quality Evaluation
The image quality evaluation of biopsy units may be
carried out as described in section 3.2.7. However, the
use of the ACR Accreditation phantom makes this task
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receptor systems, do not allow positioning of ROIs on the


image. In that case, it is suggested that the mean pixel
value from the entire image area meet the above
specification. Further, it may be necessary to infer this
mean pixel value by noting the default gray scale level at
which the image is displayed. For systems depending
totally or in part on technique charts a failure to meet the
above provisions should indicate that an adjustment to the
technique charts is warranted.

Beam quality or half value layer (see section


4.3.10)
Mean glandular dose (see section 4.3.11)
Exposure time (see section 4.3.12)
Viewbox luminance and room illuminance
(hardcopy only see section 4.3.13)
Monitor luminance and viewing conditions (see
section 4.3.14), and
Printer (hardcopy see section 4.3.15)
should be undertaken on biopsy units. The methodology
and performance criteria should mirror those discussed
previously and summarised in Appendices 3a and 5.

Biopsy testing: Medical Physics Tests

6.1
Introduction
The tests discussed in this section are, in part, based on
the ACR 1999 manual60 but with due recognition of the
fact that major developments have occurred in the
intervening time. Further, every effort has been made to
ensure that testing procedures and requirements specified
for biopsy units are consistent with those previously
specified for FFDM. As previously noted, it is also
assumed that film based units will be no longer employed
and that CR technology is not used for biopsy procedures.

Specific requirements or variations for other tests are


discussed briefly below.
6.3.1
Mammography Unit Assembly Evaluation
In addition to the features of the general inspection
carried out on FFDM units, as noted in section 4.3.1, it is
recommended that the medical physicist undertake the
following checks on biopsy units:
Technique charts are confirmed to be in place.
This applies to units both with and without AEC.
Charts must be visibly displayed near the console
clearly indicating the settings used for varying
procedures and breast types.
The X-ray tube angular locations are positively
locked and inadvertent movement from them
cannot take place
The image receptor and compression plate biopsy
window is demonstrated to be free of wobble
The vernier table drive and needle guide is rigid
and is demonstrated to be free of wobble
The localisation system zeroes coordinates
properly, and
The biopsy device is properly immobilised to
prevent recoil.

Much of section 4 applies directly to the testing of biopsy


units, however because of the small size of the detector,
the existence of three different configurations (see section
5.2) and other specialised features some new tests and
separate considerations may apply. For example, stand
alone biopsy equipment must be tested fully.
6.2

Acceptance and Equipment Upgrade only


Procedure Recommendations
The ACPSEM recommends that the following acceptance
test procedures:
Focal spot size (see section 4.2.1)
Leakage radiation (see section 4.2.2)
MTF evaluation (see section 4.2.6)
Spatial linearity & geometric distortion (see section
4.2.8)
should be performed on biopsy units. The methodology
and performance criteria should mirror those discussed
previously and summarised in Appendices 2a and 5.
Tests for missed tissue at chest wall, transmission
through breast support and threshold contrast visibility
are not recommended at this point in time.

6.3.2
Collimation and Alignment Assessment
For small FOV units the ACPSEM supports the
fundamental requirement that the FOV defined by the
biopsy window or collimator is aligned centrally with the
digital image receptor and that the X-ray field may extend
beyond the edge of the image receptor by no more than 5
mm on all four sides, where all distances are referred to
the plane of the image receptor 60.

6.3
Annual Test Procedure Recommendations
The following annual test procedures for FFDM units:
System resolution (see section 4.3.3)
Ghost image evaluation (see section 4.3.7)7
System linearity (see section 4.3.8)8
kVp performance (see section 4.3.9)

The most convenient procedure to confirm compliance


involves taping four coins on the compression paddle
tangent to the edges of the biopsy window. A loaded
film-screen cassette is placed directly behind the
compression paddle and an exposure is taken (e.g. Mo/Mo
25 kVp and 10 mAs). The definition of the X-ray field
with respect to the biopsy window may be established
from the image of the coins in the film image and the
position of the coins with respect to the image receptor in
the digital image defines the alignment of the biopsy
window with the image receptor.
From distance
measurements on the film and digital receptor, after due
correction for magnification effects, the alignment of
image receptor with the X-ray field can be inferred for
each of the four edges.

For separate image receptor systems, that do not allow


positioning of ROIs on the image, a quantitative measure of
ghosting cannot be undertaken.
8
This test can be performed on all units where the mean pixel
value for part or all of image can be extracted. However, the
detector used to monitor the air kerma may influence the
measurement so it may be necessary to employ mAs as a
surrogate for air kerma

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Increasingly, confirming compliance does present some


potential difficulties in the purely digital world. In the
absence of film it is not clear how to best perform this
test. Certainly, the digital image will allow confirmation
that the biopsy window is centred appropriately or not.
However, the alignment of the image receptor with the Xray field cannot easily be established without film. A
visual test with a fluorescent screen, in lieu of the screenfilm cassette, is unlikely to provide the required accuracy
as the required measurements are a few mm at best.
Although expensive, Gafchromic film offers some
possibility of success. It may be that a qualitative
assessment is all that can be achieved in most
circumstances.

In other respects, the ACPSEM believes the procedure


and requirements specified in section 4.3.5 should apply.
6.3.5
Image Quality Evaluation
The image quality evaluation of biopsy units may be
carried out as described in section 4.3.6. However, the
use of the ACR Accreditation phantom makes this task
clumsy with small FOV units. Rather, the ACPSEM
recommends the use of the ACR mini digital
stereotactic phantom (e.g. the NA 18-250 or equivalent)
for image quality evaluation but with the additional
proviso that a score of at least 3 fibres, 3 speck groups
and 2.5 masses must be achieved in the digitally acquired
image using the RANZCR scoring system60. This is
equivalent to the ACR requirements60. Note that if the
RMI 156S phantom is used, it is important to recognise
that it contains one less speck group and one less mass.
Thus, an acceptable score with the RMI 156S phantom is
3 fibres, 2 speck groups and 1.5 masses. It needs to be
emphasised that the image quality requirements outlined
above must be achieved with a MGD of 2.0 mGy.

6.3.3

Automatic
Exposure
Control
System
Performance Assessment / SDNR
Whenever possible, the methodology for determining the
SDNR as a function of PMMA thickness, as outlined in
sections 4.3.4, should be adopted with only minor
changes. In particular, the ROIs defining where the
SDNR is to be calculated should be placed parallel to the
chest wall and centrally in the image along the anodecathode axis on those units with a FOV of less than 100
mm square.
The SDNRs should be measured at
acceptance and monitored annually.

6.3.6
Mean Glandular dose
The mean glandular dose must be assessed using the
method shown in section 4.3.11 but for the exposure
conditions used for biopsy operation. While strictly
speaking biopsy units are not constrained to meet the dose
limits for contact mammography as specified in 4.3.11, it
is strongly recommended they adhere to these
requirements. Additionally, it is recommended that
occasional surveys of the number of exposures taken per
patient for a biopsy procedure be undertaken.

For separate image receptor systems, that do not allow


the extraction of standard deviations, the SDNR cannot be
obtained. Instead, the mean pixel value for each of the
three PMMA thicknesses is measured in the absence of
the Al foil. It is recommended that the mean pixel value,
and the SDNR, in those instances where it can be
measured, be within 10% of the previously measured
value for the respective PMMA thickness.

6.3.7
Localisation accuracy
The preferred procedure advocated by the ACPSEM and
the ACR60 is to ask a radiographer experienced in biopsy
procedures to perform a localisation using a gelatine
biopsy phantom or equivalent. The phantom should have
small (< 5 mm diameter) targets embedded within it. The
manufacturers recommended procedure for targeting a
lesion should be followed. Both pre-fire and post-fire
stereotactic images should be viewed to confirm that the
needle tip is within the lesion and beyond the lesion,
respectively. The phantom lesion material should be in
the biopsy needle after firing.

Finally, for those units that depend totally or in part on the


use of technique charts, the images should be obtained
using the clinically relevant techniques as posted on those
technique charts. For such systems a failure to comply,
with either the tolerances on the SDNR or mean pixel
value, indicates that an adjustment to the technique charts
is warranted.
6.3.4
Image Uniformity and Artefact Evaluation
Of necessity, because of the small FOV some biopsy units
have, the procedure discussed in section 4.3.5 for
determining image uniformity in FFDM must be modified
slightly. It is suggested that the four ROIs placed at the
corners of the image be located approximately 10 mm,
rather than 20 mm, from the image margins on units with
a FOV of less than 100 mm square. Some separate image
receptor systems do not allow the placement of ROIs on
the image so that a visual inspection using an
appropriately adjusted level and narrow window is all that
may be possible.

Acknowledgments

We acknowledge those who assisted in the writing of this


paper through discussions and review. Lucy Cartwright,
Mats Danielson, Ben Keir, Stewart Midgley, Lisa
Penlington, Mary Rickard, Anthony Wallace, Elizabeth
Wylie and members of the BIRG committee, Martin
Yaffe, and Ken Young.

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Appendices

Appendix 1a

Summary of Recommendations for Facility QC Procedures for DR units

Procedure

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Recommendations for Record Keepingd

Viewing Conditions

Appropriate viewing conditions

Daily

Visual inspection of ambient lighting conditions to ensure


conformance with acceptable viewing condition configuration (see
text for detail).

Checklist/logbook entry showing:


Date performed
Person performing task

All viewbox lamps must be operational and


appropriate masking available

Full Field Artefact


Evaluation

mAs = baseline 10%

Visual inspection of viewboxes for uniformity of brightness.


Confirmation of presence and operation of masking for viewboxes.
Daily

Mean pixel value in image = baseline 10%

There must be no evidence of:

Structures that are more conspicuous


than the objects in the phantom used for
weekly testing.

Blotches or regions of altered noise


appearance.

Observable grid lines or breast support


structures.

Bright or dark pixels.

Dust artefacts mimicking calcifications

Significant stitching or registration


artefacts

Expose a uniform thickness of PMMA using clinically


relevant technique factors..
Image should be acquired in processed or for presentation
form
Measure mean pixel value in 4 cm2 ROI positioned centrally
along long axis of image and 6 cm from chest wall
View image on acquisition monitor using zoom and roam to
check for possible detector faults
Print image if interpretation performed using hard copy.

Records showing:
Date test was performed.
Person performing test.
Test results

All written/electronic QC records should be retained for one year unless otherwise indicated by local Regulatory requirements. Images used to assess image quality with the ACR phantom should be
retained for a minimum of one month.

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Procedure
Monitor QC
(Monitors used for
interpretation and
attached to the
acquisition
workstation)

Monitor Cleaning

Printer area Cleanliness


(if applicable)

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Recommendations for Record Keepingd

Borders must be visible, lines must be


straight, squares must appear square, the
ramp bars should appear continuous without
any contour lines, there should be no
smearing or bleeding at black-white
transitions, all corner patches must be visible,
squares of different shades from black to
white must be distinct, all high contrast
resolution patterns and two low contrast
patterns must be visible in all four corners
and in the centre, the 5% and 95% pixel
value squares must be clearly visible, pattern
should be centred in the active area and no
disturbing artefacts should be visible on the
displayed TG18-QC test pattern.
The number of letters visible in the phrase
Quality Control for the dark, mid-gray and
light renditions should be 11.
Monitor screens must be free of dust,
fingerprints and other marks that might
interfere with image interpretation

Weekly

1.
2.
3.

Records showing:
Date test was performed.
Person performing test.
Monitor identification.
Monitor settings.
Test results

Weekly

Clean all monitor screens gently with lint-free cloth as per


manufacturers instructions.

Checklist/logbook entry showing:


Date performed
Person performing task

Clean and dust free environment

Weekly

Wet cleaning of printer area floor and open shelves. Inspect and
clean air intake filters on the film printer.

Checklist/logbook entry showing:


Date performed
Person performing task

Display TG18-QC test pattern.


Ensure viewing conditions are acceptable.
Use window-width set to maximum and window-level set to
half of maximum.

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Procedure

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Recommendations for Record Keepingd

Image Quality
Evaluation

mAs = baseline 10%

Weekly

Obtaining the phantom image:


1. Use of ACR mammography image quality phantom.
2. Use of a consistent AEC detector position where this is
manually selected
3. Light contact between the compression paddle and the
phantom surface.
4. Consistent positioning of the phantom.
5. Consistent selection of clinically relevant kVp and target/filter
combinations.
6. Selection of the density setting in current clinical use (if
applicable).

Record numerical mAs values and image quality


scores

For hard copy reporting optical density =


baseline 20%
The ability to clearly visualise 5 fibres, 3.5
speck groups (4 is desirable) & 4 masses in
an image of an ACR accreditation phantom

Evaluating the phantom image (preferably on reading workstation


or on printed copy if hardcopy reporting used):
1. Use for presentation image with zoom and modest
adjustment of window/level functions to score fibres and
specks
2. Use consistent (baseline) viewing conditions that reflect those
used to read actual mammograms.
3. Image quality scoring by the same person, if possible
4. Measure optical density in reproducible part of phantom image
if hardcopy reporting.
5. Use of a control chart to record results.
Detector Calibration
Flat Field Test

Pass or Fail

Signal Difference to
Noise Ratio (SDNR)

SDNR = baseline 20%

Weekly or as
per
manufacturers
requirements
Weekly

Control chart showing:


Plots of mAs, image quality score/s, and OD
if applicable
25 results.
Clearly marked control limits.
Baseline values
Radiographic settings (kVp, target/filter
combination, density setting and SID)
Remarks e.g. corrective action.

Phantom images identifying:


Date
The X-ray system
The technique factors.

Follow manufacturers specific procedure

Checklist/logbook entry showing:


Date performed
Person performing task

Preferably follow manufacturer procedure. Alternatively::


1. Use the for presentation image obtained with ACR phantom
for image quality purposes but with PMMA disc on paddle:
2. Measure the mean pixel value (MPV1) and SD in a small ROI
next to PMMA disc
3. Measure mean pixel value (MPV2) in ROI centred in disc
4. Calculate SDNR = (MPV1 MPV2)/SD

Records showing:
Date test was performed.
Person performing test.
X-ray system identification.
kVp, target/filter, AEC mode and mAs.
Test results

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Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Recommendations for Record Keepingd

Monthly for
dry lasers and
daily or as used
for wet lasers

1.
2.

Print the TG18-QC test pattern.


Check visibility and distortion of several items used for
evaluating the quality of the image.
Check for disturbing artefacts.
Measure MD, DD, B+F and Dmax.

Control charts & records showing:


Date test was performed.
Person performing test.
Printer identification.
Test results

Mechanical Inspection

Borders must be visible, lines must be


straight, all corner patches must be visible,
squares of different shades from black to
white must be distinct, all high contrast
resolution patterns must be visible in all four
corners and the centre, the 5% and 95% pixel
value squares must be clearly visible, and no
disturbing artefacts should be visible on the
printed TG18-QC test pattern.
The number of letters visible in the phrase
Quality Control for the dark, mid-gray and
light renditions should be 11.The mid
density (MD) and density difference (DD) =
baseline 0.15
Base + fog (B+F) = baseline 0.03 & 0.25
Dmax = baseline 0.10 & 3.4
Indicated breast thickness accurate to 5 mm

Monthly

1.
2.

Checklist/logbook entry showing:


Date inspection performed
Inspection results
Person performing test

Repeat Analysis

No hazardous, inoperative, out of alignment


or improperly operating items on the system.
All items listed on the visual check list have
received a pass.
Repeat rate <3% (<2% preferred)

Confirm accuracy of thickness indication


Visual inspection of the system to ensure safe and optimum
operation.

Quarterly

1.

Inclusion of images from at least 250 consecutive client


examinations.
The ability to determine repeat rates attributable to a range of
equipment faults and positioning errors.

Worksheet/logbook entries showing all


results/calculations.

Use manufacturers protocol and test block if available;


otherwise
Image a standard test block at clinical settings.
On the for processing image, draw 100 mm2 square or
circular ROIs in the centre and four corners
If the mean pixel value of a ROI deviates by more than 15%
from the mean pixel value in the central ROI, the detector gain
map may require re-calibration
If required, to exclude failure due to non uniformities in the
standard test block, rotate latter by 180 o and repeat
measurement.

Records showing:
Date test was performed.
Person performing test.
X-ray system identification.
kVp, target/filter, density setting and mAs.
Test results

Assess for both contact and magnification modes.


Use PMMA thickness between 2 and 6 cm covering complete
image receptor
Use clinical AEC settings (kVp, target/filter and mode)
Measure mean pixel value in 4 cm2 ROI positioned centrally
along axis and 6 cm from chest wall
Examine image for clinically significant artefacts

Records showing:
Date test was performed.
Person performing test.
X-ray system identification.
kVp, target/filter, AEC mode and mAs.
Test results

Procedure
Printer QC (if
applicable)

3.
4.

2.
Image Receptor
Homogeneity

Maximum deviation in mean pixel value in


ROI < 15% of mean pixel value in central
ROI.
Maximum variation of the mean pixel value
in central ROI between successive quarterly
images < 10%.

Quarterly or
more
frequently if
recommended
by the
manufacturer

1.
2.
3.
4.

5.

AEC Calibration Test

Mean pixel value for each of 2, 4 and 6 cm


PMMA within 10% of baseline values

Quarterly

1.
2.
3.
4.
5.

26

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Recommendations for Record Keepingd

Compression

Maximum motorised compression force in


range 150 - 200 N

Six monthly

Confirm machine indicated compression force meets requirements

Checklist/logbook entry showing:


Date test performed
Test results
Person performing test

Optical density measurement accurate to


within:
0.03 (0 -3.0 OD)
3% (3.0 - 4.0 OD)

Six monthly

Verification of accuracy using an optical density calibration strip


traceable to an accepted standard

Checklist/logbook entry showing:


Date test performed
Test results
Person performing test

Maintenance & Fault


Logging

Separate logbooks for each imaging system


including diagnostic monitors & film printer
if relevant.

As required

Dated entries describing fault encountered and/or maintenance


performed.

Logbooks with dated and initialled entries.

Infection Control of
Breast Imaging
Equipment

Clean equipment

Before each
examination

Cleaning using alcohol swipes, or as per manufacturer's


recommendations and/or suitable infection control advice

Nil.

Test Equipment Quality


Control

Densitometer
calibration check

27

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0

Appendix 1b

Summary of Recommendations for Facility QC Procedures for CR Units

Procedure

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Recommendations for Record Keeping d

Viewing Conditions

Appropriate viewing conditions

Daily

Visual inspection of ambient lighting conditions to ensure


conformance with acceptable viewing condition configuration (see
text for detail).

Checklist/logbook entry showing:


Date performed
Person performing task

All viewbox lamps must be


operational and appropriate masking
available
Image Plate Erasure

Erasure of energy absorbed from


scattered radiation or naturally
occurring radiation by CR image
plates before they are used.

Visual inspection of viewboxes for uniformity of brightness.


Confirmation of presence and operation of masking for viewboxes.
Daily/Weekly

On a daily basis or if left unused for more than 8 hours, all CR


image plates should be subjected to an erasure (following
manufacturers instructions).

Logbooks with dated and initialled entries.

On a weekly basis all Fuji CR image plates should be subjected to


a primary erasure.
Monitor/Viewboxes Cleaning

Monitor screens and viewboxes must


be free of dust, fingerprints and other
marks that might interfere with image
interpretation

Weekly

Clean all monitor screens and viewboxes gently with lint-free cloth
as per manufacturers instructions.

Checklist/logbook entry showing:


Date performed
Person performing task

All written QC records should be retained for a minimum of one year unless otherwise indicated by local Regulatory requirements. Images used to assess image quality with the ACR phantom should
be retained for a minimum of one month.

28

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure
Monitor QC (Monitors used
for interpretation and attached
to the acquisition workstation)

Monitor Cleaning

Printer area Cleanliness (if


applicable)

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Recommendations for Record Keeping d

Borders must be visible, lines must be


straight, squares must appear square,
the ramp bars should appear
continuous without any contour lines,
there should be no smearing or
bleeding at black-white transitions, all
corner patches must be visible,
squares of different shades from black
to white must be distinct, all high
contrast resolution patterns and two
low contrast patterns must be visible
in all four corners and the centre, the
5% and 95% pixel value squares must
be clearly visible, pattern should be
centred in the active area and no
disturbing artefacts should be visible
on the displayed TG18-QC test
pattern.
The number of letters visible in the
phrase Quality Control for the dark,
mid-gray and light renditions should
be 11.

Weekly

1.
2.
3.

Records showing:
Date test was performed.
Person performing test.
Monitor identification.
Monitor settings.
Test results

Monitor screens must be free of dust,


fingerprints and other marks that might
interfere with image interpretation
Clean and dust free environment

Weekly

Weekly

Display TG18-QC test pattern.


Ensure viewing conditions are acceptable.
Use window-width set to maximum and window-level set to
half of maximum.

Clean all monitor screens gently with lint-free cloth as per


manufacturers instructions.

Checklist/logbook entry showing:


Date performed
Person performing task

Wet cleaning of printer area floor and open shelves. Inspect and
clean air intake filters on the film printer.

Checklist/logbook entry showing:


Date performed
Person performing task

29

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Recommendations for Record Keeping d

Image Quality Evaluation

mAs = baseline 10%

Weekly

Obtaining the phantom image:


1. Use an ACR accreditation phantom or suitable mammography
image quality phantom.
2. Use of a designated test cassette and imaging plate that is in
routine clinical use.
3. Use of a consistent AEC detector position where this is
manually selected
4. Light contact between the compression paddle and the
phantom surface.
5. Consistent positioning of the phantom.
6. Consistent selection of clinically relevant kVp and target/filter
combinations.
7. Selection of the density setting in current clinical use.
8. Consistent time delay between plate irradiation and readout.

Record numerical mAs values and image quality


scores

Dose to plate = baseline 10%


Exposure indicator (see Appendix 6
for manufacturer dependent
tolerances)
For hard copy reporting optical
density = baseline 20%
The ability to clearly visualise 5
fibres, 3.5 speck groups (4 is
desirable) & 4 masses in an image of
an ACR accreditation phantom

Evaluating the phantom image (preferably on reading workstation


or on printed copy if hardcopy reporting used):
1. Use for presentation image with zoom and modest
adjustment of window/level functions to score fibres and
specks
2. Use of consistent viewing conditions that reflect those used to
read actual mammograms. This applies to both soft and hard
copy
3. Image quality scoring by the same person, if possible.
4. Measure optical density in reproducible part of phantom image
if hardcopy reporting.
5. Use of a control chart to record results.

30

Control chart showing:


Plots of mAs, exposure indicator, image
quality score/s and OD if applicable
25 results.
Clearly marked control limits.
Baseline values
Radiographic settings (kVp, target/filter
combination, density setting and SID)
Remarks e.g. corrective action.

Phantom images identifying:


Date
The x-ray system
The technique factors.

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure
Printer QC

Mechanical Inspection

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Recommendations for Record Keeping d

Borders must be visible, lines must be


straight, all corner patches must be
visible, squares of different shades
from black to white must be distinct,
all high contrast resolution patterns
must be visible in all four corners and
the centre, the 5% and 95% pixel
value squares must be clearly visible,
and no disturbing artefacts should be
visible on the printed TG18-QC test
pattern.
The number of letters visible in the
phrase Quality Control for the dark,
mid-gray and light renditions should
be 11
The mid density (MD) and density
difference (DD) = baseline 0.15
Base + fog (B+F) = baseline 0.03 &
0.25
Dmax = baseline 0.10 & 3.4

Monthly for
dry lasers and
daily or as
used for wet
lasers

1.
2.

Print the TG18-QC test pattern.


Check visibility and distortion of several items used for
evaluating the quality of the image.
Check for disturbing artefacts.
Measure MD, DD, B+F and Dmax.

Control charts & records showing:


Date test was performed.
Person performing test.
Printer identification.
Test results

Indicated breast thickness accurate to


5 mm

Monthly

1.
2.

Confirm accuracy of thickness indication


Visual inspection of the system to ensure safe and optimum
operation

Checklist/logbook entry showing:


Date performed
Inspection results
Person performing task

Inclusion of images from at least 250 consecutive client


examinations.
The ability to determine repeat rates attributable to a range of
equipment faults and positioning errors.

Worksheet/logbook entries showing all


results/calculations.

No hazardous, inoperative, out of


alignment or improperly operating
items on the system.
All items listed on the visual check
list have received a pass.
Repeat Analysis

Repeat rate <3% (<2% preferred)

3.
4.

Quarterly

1.
2.

31

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Image Receptor Homogeneity

Maximum difference in mean pixel


value between any two ROIs < 10%

Quarterly or
more
frequently if
recommended
by the
manufacturer)

1.

Maximum variation of the mean pixel


value in central ROI between
successive QC images < 10%.

2.
3.
4.

5.

6.
7.

AEC Calibration Test

Dose to plate for each of 2, 4 and 6


cm PMMA = baseline 10%

Quarterly

See Appendix 6 for equivalent


manufacturer specific exposure index
requirements

1.
2.
3.
4.
5.
6.
7.

Compression

Recommendations for Record Keeping d

Use manufacturers protocol and test block if available;


otherwise
Image a standard test block at clinical settings.
Use test cassette
Perform measurements on the for processing (unprocessed)
image, if possible, using a 100 mm2 square or circular ROI.
Three ROIs are placed at the left, right and centre on a line
20mm back from chest wall.
If the mean pixel value of any two ROIs differ by more than
10% from each other, the CR units shading correction may
require re-calibration or imaging plate(s) may require
replacement
If ROI analysis is not possible, do a visual inspection at
narrow window width.
If required, to exclude failure due to non uniformities in the
standard test block, rotate by 180 o and repeat measurement

Records showing:
Date test was performed.
Person performing test.
X-ray system identification.
kVp, target/filter, density setting and mAs.
Test results

Assess for both contact and magnification modes.


Use PMMA thickness between 2 and 6 cm covering complete
cassette
Use clinical AEC settings (kVp, target/filter and mode
including density setting)
Use a designated test cassette and imaging plate that is in
routine clinical use
Use a consistent AEC detector position where this is manually
selected.
Consistent positioning of the PMMA.
Consistent time delay between plate irradiation and readout.

Records showing:
Date test was performed.
Person performing test.
X-ray system identification.
kVp, target/filter, AEC mode and mAs.
Test results

Maximum motorised compression


force in range 150 - 200 N

Six monthly

Confirm machine indicated compression force meets requirements

Checklist/logbook entry showing:


Date test performed
Test results
Person performing test

Optical density measurement accurate


to within:
0.03 (0 -3.0 OD)
3% (3.0 - 4.0 OD)

Six monthly

Verification of accuracy using an optical density calibration strip


traceable to an accepted standard

Checklist/logbook entry showing:


Date test performed
Test results
Person performing test

Test Equipment Quality Control

Densitometer calibration
check

32

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Recommendations for Record Keeping d

Procedure

Recommended ControlLimits/Requirements

Minimum
Frequency

Key Procedure Elements

Cassette/Image Plate Condition


and Inter Plate Sensitivity
Variation

Clean and dust free cassettes & image


plates
No major inhomogeneities on the
images
See Appendix 6 for manufacturer
specific tolerances on interplate
variations

Six monthly

1.

Maintenance & Fault Logging

Separate logbooks for each imaging


system, including diagnostic
monitors, & film printer if relevant.

As required

Dated entries describing fault encountered and/or maintenance


performed.

Logbooks with dated and initialled entries.

Infection Control of Breast


Imaging Equipment

Clean equipment

Before each
examination

Cleaning using alcohol wipes, or as per manufacturer's


recommendations and/or suitable infection control advice

Nil.

2.
3.
4.

Cassette/image plate cleaning as per manufacturers


recommendations
Image a standard test block at clinical settings.
Pre processing should be turned off as much as possible and
no post processing should be applied.
Evaluate for artefact on both film (if applicable) and monitor

33

Records showing:
Date test was performed.
Person performing test.
kVp, target/filter, AEC mode.
Exposure indicator and mAs for each plate.

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0

Appendix 2

Summary of Recommendations for Medical Physics Testing only at Acceptance or Equipment Upgrade

Procedure

Performance Requirements / Guidelines

Routine Testing Guidelines

Key Procedure Elements

Focal Spot

Not required unless tube has been changed.

As per section 4.2.1


or AS/NZS 427426

Not required unless tube has been changed or system


relocated.

As per AS/NZS 3200.1.327


As per AS/NZS 3200.1.3 27

11 lp/mm for line-pair bars perpendicular to anode-cathode axis and


13 lp/mm for line-pair bars parallel to anode-cathode axis.

OR complies with AS/NZS 4274 26 for 0.3 and 0.1 mm focal spot sizes
Leakage Radiation

Transmission Through Breast


Support

0.001 mGy @ max kVp and mAs

Not required unless change made to image receptor


system.

Missed Tissue @ Chest Wall

Width of missed tissue at chest wall 5 mm in contact mode and 7 mm in


magnification mode

Not required unless tube has been changed or change


made to image receptor system or system relocated.

Plate Fogging (CR only)

Image of coin should not be visible.

Not required unless changes in storage of cassettes have


occurred

Monitor during acceptance


testing

MTF

Bench mark testing, compare to manufacturers specification.

Not required unless tube has been changed or change


made to image receptor system.

As per IEC 62220-1-235

Threshold Contrast Visibility

Not required unless tube has been changed or change


made to image receptor system.

Use CDMAM phantom*

Spatial Linearity & Geometric


Distortion

Not required unless change made to image receptor


system.

Use wire mesh tool.

Not required unless change made to image receptor


system.

Use steel rulers. Determine


dimensions in image, ideally
using reporting workstation.

Distance Calliper Accuracy

1 mGy/hr at 1m from focus and


0.01 mGy/100 mAs @ 30 kVp & 30 cm from focus

Measured dimensions of ruler in image should be within 2% of true dimensions in


plane specified by manufacturer
Check both contact and magnification modes

* This test allows digital systems to be benchmarked against European standards 9. No alternative test is known at this stage.

34

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0

Appendix 3a

Summary of Recommendations for Medical Physics Annual Testing of DR Units

Procedure

Performance Requirements / Guidelines

Routine Testing Guidelines

Acceptance & Additional


Tests

Mammography Unit Assembly


Evaluation

Correct and safe function of system components. Thickness display accuracy within
5 mm, note: Flexi paddles will not comply (manufacturer recommendation varies
~ 11-12 mm for flexi paddles). Reproducible to 2mm. Verify DICOM image header
for correct display of parameters.

Confirm function of all motorised components, warning


lights, displays etc. Evaluate system for any
miscellaneous safety risks etc. DICOM verification
required after software upgrades

As per routine tests.

The X-ray field shall irradiate the image receptor fully but not extend beyond the
chest wall edge of the image receptor by more than 2% of the SID

Assess alignment for each target/geometry combination.

As per routine tests.

The chest wall edge of the compression paddle shall be aligned just beyond the chest
wall edge of the image receptor such that it does not appear in the image. In
addition, the compression paddle shall not extend beyond the chest wall edge of the
image by more than 1% of the SID.

Assess alignment for all clinically relevant


Bucky/paddle/target/geometry combinations.

As per routine tests.

Compare to baseline values, variation less than 10%

Measure MTF using system software if possible.


Otherwise measure limiting resolution:
1. Use a 4cm PMMA block or equivalent.
2. Place resolution pattern on PMMA
3. Measure both parallel and perpendicular to chest wall
4. Repeat for Magnification mode if applicable.

Establish base line values

Coefficient of variation (COV) for both absorbed dose and mAs for at least three
phototimed exposures of a test object shall be better than or equal to 0.05.

1. Use a 4cm PMMA block or equivalent.


2. Assess COV for each AEC detector at a typical clinical
kVp.

As per routine tests.

Collimation & Alignment


Assessment

X-ray field / Image receptor


alignment

Paddle / Image alignment

System Resolution/ MTF

AEC System Performance


Assessment

Reproducibility

Compensation & SDNR


System Performance
Assessment

Compare SDNR values to baseline and to the minimum acceptable values for 4 cm
PMMA (SDNRaccept):
SDNR2cm > 1.1 SDNRaccept
SDNR4cm > SDNRaccept
SDNR6cm > 0.9 SDNRaccept

1. Assess the most commonly used AEC modes for


contact and magnification geometry.
2. Use 0.2 mm Al foil as contrast test tool and measure
SDNR for 2, 4 and 6 cm PMMA (also see section on
glandular dose). Note: measurements are to be
undertaken on for processing (unprocessed) images

Establish baseline values.


Assess all available AEC
modes for contact and
magnification geometries.

Density control (if


applicable)

The density control should be capable of changing the mAs from the value used
normally by -25% to +50%

Assess change in mAs for at least two density settings


either side of the usual clinical setting using 4 cm of
PMMA

Assess change in mAs across


full range of density settings.

Back-up timer / security


cut-out

Security cut-out mechanisms shall be present & terminate the exposure within 50 ms
or within 5 mAs or with an entrance absorbed dose for the ACR accreditation
phantom of less than 0.44 mGy. In absence of security cut-out a back-up timer shall
terminate exposure at 600 mAs.

Confirm that the back-up timer / security cut-out is


functioning in the typical fashion.

Confirm that the security cutout functions within the


limits specified.

35

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure

Performance Requirements / Guidelines

Routine Testing Guidelines

Acceptance & Additional


Tests

Image Uniformity & Artefact

1. Assess for 40 mm PMMA covering complete detector.


2. Use five ROIs (one central, with the other 4
approximately 20 mm from any edge) each of 100
mm2.
3. Measurements performed on unprocessed image
4. Exclude phantom non uniformity by rotating block
180 and repeating.
5. Repeat in magnification mode if applicable

Assess also at 20 mm and 60


mm

Max. deviation of mean pixel value < 15% of mean pixel value for central
ROI
Max. deviation in SNR as a function of time is 10%.
There must be no evidence of blotches or regions of altered noise appearance,
observable grid lines or breast support structures, bright or dark pixels

Detector Element Failure

Limits currently not established. Must monitor independent of manufacturer.


Inspect bad pixel map.

A mammographic screen-film mesh can be used to


determine if correction for bad columns successful.

Bad pixel map must be


available at any time,
independent of manufacturer.

Image Quality Evaluation

The ability to clearly visualise 5 fibres, 3.5 speck groups (4 is desirable) & 4 masses
in an image of an ACR accreditation phantom

Use typical clinical settings.

As per routine testing

Ghost Image Evaluation

Ghost image factor < 2.0

Assess using 40 mm PMMA (see section 4.3.7 for testing


guidelines).

As per routine testing

System Linearity & Noise


Analysis

1. Use standard test block (e.g. 4 cm PMMA) at typical


clinical beam settings.
2. Measure ESAK at 6 cm from chest wall
3. Measure mean pixel value and SD in ROI placed 6 cm
from chest wall.
4. Plot mean pixel value as a function of ESAK.
5. Plot SD2 as a function of MPV corrected for any pixel
offset.

Baseline measurements at
clinical kVp, also at max and
min clinical kVps for all
target filter combinations

COV 0.02 for a minimum of three exposures.

Assess kVp reproducibility at typical clinical kVp.

Assess kVp, output & timer


reproducibility.

Measured kVp shall be within 5% of the specified value over the clinically
relevant range

Assess kVp accuracy over the clinically relevant range in,


at most, 2 kVp increments Note: The kVp need only be
verified for one target filter combination per kVp,
however the kVp meter must be calibrated for that
particular target/filter combination.

Assess kVp accuracy over


clinically relevant range in 1
kVp increments.

[(kVp/100) + 0.03] HVL< [(kVp/100) +C]


where
C
= 0.12 mm Al for Mo/Mo
= 0.19 mm Al for Mo/Rh
= 0.22 mm Al for Rh/Rh
= 0.30 mm Al for W/Rh
= 0.32 mm Al for W/Ag
= 0.25 mm Al for W/Al

Measure the HVL required for Mean Glandular Dose


calculations.

As per routine tests plus


measure HVL at 28 kVp for
all target/filter combinations,
with the compression paddle
removed if unit used for
biopsy purposes with open
paddle.

Linearity plot versus ESAK: R2>0.99


SD2 plot versus MPV: R2>0.99
Noise parameters: Compare to baseline results

Generator Performance
(optional)

kVp, output, and timer


reproducibility
kVp accuracy

Beam Quality

36

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure

Performance Requirements / Guidelines

Routine Testing Guidelines

Acceptance & Additional


Tests

Mean Glandular Dose

2.0 mGy for a 4.2 cm 50% adipose, 50% glandular breast (i.e. ACR
accreditation phantom).
<1 mGy for 2.0 cm PMMA (2.3 cm 50% adipose, 50% glandular breast)
< 4.5 mGy for 6.0 cm PMMA, (6.5 cm 50% adipose, 50% glandular breast)

Assess for an AEC controlled exposure using typical


clinical settings using ACR phantom and also for 20 mm
and 60 mm PMMA.

As per routine tests.

Exposure Time

For all clinically relevant SID settings the maximum exposure time when irradiating
6 cm PMMA should be less than 3.5 seconds and 2 seconds for fine and broad focus,
respectively.

1. Assess for both contact and magnification modes.


2. Use 6 cm of PMMA
3. Use clinically relevant technique factors for this
PMMA thickness consistent with SDNR and MGD
measurements
4. Record mAs and infer the exposure time from tube
rating or measure directly using a manual exposure
matched to mAs needed for AEC initiated exposure.

As per routine tests.

Viewbox Luminance and Room


Illuminance (Hardcopy only)

Viewing area illuminance 50 lux


Viewbox luminance 3000 cd/m2

Assess viewing conditions for all viewers

As per routine tests.

Monitor Luminance & Viewing


Conditions

Image interpretation must not be done on a monitor of less than 5 mega pixels
Luminance dynamic range > 250:1
Maximum luminance >450 cd/m2 ( >240 cd/m2 for CRT displays)
Ambient light < 20 lux
In PACS situations images must be stored with lossless compression.

1. Measure dynamic range under clinical lighting


conditions
2. Confirm luminance uniformity
3. Confirm GSDF
4. Confirm no cross-talk & pixel defects

As per routine testing.


Monitor or workstation may
have comprehensive QC
program which needs to be
validated.

Monitor Performance

No smearing artefact, ramps without terracing.


Lines straight, boxes square, active display centred, borders complete
Free from artefact
The number of letters visible in the phrase Quality Control for the dark, midgray and light renditions should be 11.

1. Test patterns to be displayed at full resolution


2. Test under clinical lighting conditions
3. Use TG18-QC test pattern.

As per routine testing.


Monitor or workstation may
have comprehensive QA
program

Printer (Hardcopy only)

B+F = baseline 0.03 & 0.25 OD


Dmax = baseline 0.10 & 3.4 OD
The number of letters visible in the phrase Quality Control for the dark, midgray and light renditions should be 11.

Print TG18-QC test pattern as per weekly printer QC test

As per routine tests.

37

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0

Appendix 3b Summary of Recommendations for Medical Physics Annual Testing of CR Units


Procedure

Performance Requirements / Guidelines

Routine Testing Guidelines

Acceptance & Additional


Tests

Mammography Unit Assembly


Evaluation

Correct and safe function of system components. Thickness display accuracy within
5 mm, reproducible to 2mm. Verify DICOM image header for correct display of
parameters.

Confirm function of all motorised components, warning


lights, displays etc. Evaluate system for any
miscellaneous safety risks etc. DICOM verification
required after software upgrades

As per routine tests.

The X-ray field shall irradiate the image receptor fully but not extend beyond the
chest wall edge of the image receptor by more than 2% of the SID

Assess alignment for largest collimator in clinical use for


each Bucky/target combination. For magnification
geometry only assess chest wall alignment.

As per routine tests.

The chest wall edge of the compression paddle shall be aligned just beyond the chest
wall edge of the image receptor such that the chest wall compression paddle does not
appear in the image. In addition the compression paddle shall not extend beyond the
chest wall edge of the image receptor by more than 1% of the SID

Assess alignment for all clinically relevant


Bucky/paddle/geometry combinations.

As per routine tests.

Compare to baseline values, variation less than 10%

Measure MTF using system software if possible.


Otherwise measure limiting resolution:
1. Use a 4cm PMMA block or equivalent.
2. Place resolution pattern on PMMA
3. Measure both parallel and perpendicular to chest wall
4. Repeat for Magnification mode if applicable.

Establish base line values

Coefficient of variation (COV) for both absorbed dose and mAs for at least three
phototimed exposures of a test object shall be better than or equal to 0.05.

1. Use a 4cm PMMA block or equivalent.


2. Assess COV for each AEC detector at a typical clinical
kVp.

As per routine tests.

Collimation & Alignment


Assessment

X-ray field / image /breastsupport alignment

Paddle / Image alignment

System Resolution/ MTF

AEC System Performance


Assessment

Reproducibility

38

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure

Performance Requirements / Guidelines

Routine Testing Guidelines

Acceptance & Additional


Tests

Compare SDNR values to baseline and to the minimum acceptable values for 4 cm
PMMA (SDNRaccept):
SDNR2cm > 1.1 SDNRaccept
SDNR4cm > SDNRaccept
SDNR6cm > 0.9 SDNRaccept

1. Assess the most commonly used AEC modes for


contact and magnification geometry.
2. Use clinical AEC settings (kVp, target/filter and mode
including density setting)
3. Use a designated test cassette and imaging plate that is
in routine clinical use
4. Use a consistent AEC detector position where this is
manually selected.
5. Use 0.2 mm Al foil as contrast test tool and measure
SDNR for 2, 4 and 6 cm PMMA (also see section on
glandular dose). Note: measurements are to be
undertaken on for processing (unprocessed) image
6. Consistent time delay between plate irradiation and
readout.
7. Record exposure indicator for each PMMA thickness
8. Measure film density for each image if applicable.

Establish baseline values.


Assess all available AEC
modes for contact and
magnification geometries.
Assess both 18x24 cm2 &
24x30 cm2 Buckys.

The density control should be capable of changing the mAs from the value used
normally by -25% to +50%

Assess change in mAs for at least two density settings


either side of the usual clinical setting using 4 cm of
PMMA

Assess change in mAs across


full range of density settings.

Security cut-out mechanisms shall be present & terminate the exposure within 50 ms
or within 5 mAs or with an entrance absorbed dose for the ACR accreditation
phantom of less than 0.44 mGy. In absence of security cut-out a back-up timer shall
terminate exposure at 600 mAs.

Confirm that the back-up timer / security cut-out is


functioning in the typical fashion.

Confirm that the security cutout functions within the


limits specified.

Max. deviation of mean pixel value < 10% of mean pixel value for central ROI

1. Assess for 40 mm PMMA covering complete CR plate.


2. Use three ROIs each of ~100 mm2 placed on a line
parallel to and approximately 20 mm from chest wall

Assess also at 20 mm and 60


mm

Compensation & SDNR


System Performance
Assessment

Note: For Magnification mode this last requirement is relaxed to:


SDNR6 cm > 0.65 x SDNRaccept

Density control

Back-up timer / security


cut-out

Image Uniformity & Artefact

Max. deviation in SNR of central ROI as a function of time is 10%.


No major inhomogeneities on the images
Uniformity of Cassette/Image
Plate Response

1. Assess for 40 mm PMMA covering complete CR plate.

Maximum mAs variation <5% between all plates of one size.


Maximum mAs variation <20% between plates of different sizes.
See Appendix 6 for manufacturer dependent allowed tolerances on the exposure
indicator

Image Quality Evaluation

The ability to clearly visualise 5 fibres, 3.5 speck groups (4 is desirable) & 4 masses
in an image of an ACR accreditation phantom

Use typical clinical settings.

As per routine testing

Ghost Image Evaluation

Ghost image factor < 2.0

Assess using 40 mm PMMA (see section 4.3.7 for testing


guidelines).

As per routine testing

39

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure

Performance Requirements / Guidelines

Routine Testing Guidelines

Acceptance & Additional


Tests

System Linearity & Noise


Analysis

Compare to baseline results and note requirement for linearity (see text and
Appendix 6) has R2>0.99.
Noise analysis remains optional.

1. Use standard test block (e.g. 4 cm PMMA) at typical


clinical beam settings.
2. Use the same cassette/image plate for all exposures.
3. Record exposure indicator.
4. Plot exposure indicator as a function of ESAK (see
Appendix 6).

Baseline measurements at
clinical kVp, also at max and
min clinical kVps for all
target filter combinations

COV 0.02 for a minimum of three exposures.

Assess at least kVp reproducibility at typical clinical kVp.

Assess kVp, output & timer


reproducibility.

Measured kVp shall be within 5% of the specified value over the clinically
relevant range

Assess kVp accuracy over the clinically relevant range in,


at most, 2 kVp increments

Assess kVp accuracy over


clinically relevant range in 1
kVp increments.

Beam Quality

[(kVp/100) + 0.03] HVL< [(kVp/100) +C]


where
C
= 0.12 mm Al for Mo/Mo
= 0.19 mm Al for Mo/Rh
= 0.22 mm Al for Rh/Rh
= 0.30 mm Al for W/Rh
= 0.32 mm Al for W/Ag
= 0.25 mm Al for W/Al

Measure the HVL required for Mean Glandular Dose


calculations.

As per routine tests plus


measure HVL at 28 kVp for
all target/filter combinations,
with the compression paddle
removed if unit used for
biopsy purposes with open
paddle.

Mean Glandular Dose

Assess for an AEC controlled exposure using typical


clinical settings using ACR phantom and also for 20 mm
and 60 mm PMMA.

As per routine tests.

Generator Performance
(optional)

kVp, output, and timer


reproducibility
kVp accuracy

2.0 mGy for a 4.2 cm 50% adipose, 50% glandular breast (i.e. ACR
accreditation phantom).
<1 mGy for 2.0 cm PMMA (2.3 cm 50% adipose, 50% glandular breast)
< 4.5 mGy for 6.0 cm PMMA, (6.5 cm 50% adipose, 50% glandular breast)

Exposure Time

For all clinically relevant SID settings the maximum exposure time when irradiating
6 cm PMMA should be less than 3.5 seconds and 2 seconds for fine and broad focus,
respectively.

1. Assess for both contact and magnification modes.


2. Use 6 cm of PMMA
3. Use clinically relevant technique factors for this
PMMA thickness consistent with SDNR and MGD
measurements
4. Record mAs and infer the exposure time from tube
rating or measure directly using a manual exposure
matched to mAs needed for AEC initiated exposure.

As per routine tests.

Viewbox Luminance and Room


Illuminance (Hardcopy only)

Viewing area illuminance 50 lux


Viewbox luminance 3000 nit

Assess viewing conditions for all viewers

As per routine tests.

Monitor Luminance & Viewing


Conditions

Image interpretation must not be done on a monitor of less than 5 mega pixels
Luminance dynamic range > 250:1
Maximum luminance >450 cd/m2 ( >240 cd/m2 for CRT displays)
Ambient light < 20 lux
In PACS situations images must be stored with lossless compression

1. Measure dynamic range under clinical lighting


conditions
2. Confirm luminance uniformity
3. Confirm GSDF
4. Confirm no cross-talk & pixel defects

As per routine testing.


Monitor or workstation may
have comprehensive QC
program which needs to be
validated.

40

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0


Procedure

Performance Requirements / Guidelines

Routine Testing Guidelines

Acceptance & Additional


Tests

Monitor Performance

No smearing artefact, ramps without terracing.


Lines straight, boxes square, active display centred, borders complete
Free from artefact
The number of letters visible in the phrase Quality Control for the dark, midgray and light renditions should be 11.

1. Test patterns to be displayed at full resolution


2. Test under clinical lighting conditions
3. Use TG18-QC test pattern.

As per routine testing.


Monitor or workstation may
have comprehensive QA
program

Printer (Hardcopy only)

B+F = baseline 0.03 & 0.25 OD


Dmax = baseline 0.10 & 3.4 OD
The number of letters visible in the phrase Quality Control for the dark, midgray and light renditions should be 11.

Print TG18-QC test pattern as per weekly printer QC test

As per routine tests.

41

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0

Appendix 4

Summary of Recommendations for Facility QC for Biopsy units

Procedure

Minimum
Frequency

Fully integrated
digital/biopsy unit

Digital mammography with


add on image system

Stand alone biopsy system

Viewing Conditions

Weekly

Previously covered

Previously covered

See section 3.2.1

Monitor QC

Weekly

Previously covered

ssa

See section 3.2.4

Monitor Cleaning

Weekly

Previously covered*

ssa

See section 3.2.5

Image Quality Evaluation

Weekly

ssa

ssa

See section 3.2.7 Note may use ACR mini digital stereotactic phantom see text.

Printer QC (if applicable)

Weekly

Previously covered

ssa

See section 3.2.10

Mechanical Inspection

Monthly

ssa

ssa

See section 3.2.11 Note Additionally image receptor and compression plate/ biopsy window must be free
of wobble; Vernier drive and needle guide rigid and wobble free, localisation system zeros and biopsy
device properly immobilised see text.

Repeat Analysis

Quarterly

ssa

ssa

See section 3.2.12

Image Receptor Homogeneity

Quarterly**

Previously covered

ssa

See section 3.2.13 Note; procedure should be modified as seen in text.

AEC Calibration Test

Quarterly

ssa

ssa

See section 3.2.14 Procedure may vary for different types of units see text.

Compression

Six monthly

ssa

ssa

See section 3.2.15

Test Equipment Quality Control

Six monthly

Previously covered

Previously covered

See section 3.2.16

Maintenance & Fault Logging

As required

ssa

ssa

See section 3.2.18

Infection Control of Breast


Imaging Equipment

Before each
examination

Previously covered

Previously covered

See section 3.2.19

Stereotactic Accuracy
Confirmation

Prior to first use


on day of
procedures

ssa

ssa

Localisation within 1 mm. Procedure as per manufacturer's recommendations; Checklist/logbook entry


showing:

Densitometer calibration check

Date test performed


Test results
Person performing test

*test previously completed as part of mammography tests


ssa see Stand alone biopsy units
** or more frequently if recommended by the manufacturer

42

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0

Appendix 5

Summary of Recommendations for Medical Physics Testing for Biopsy units

Procedure

Frequency

Fully integrated
digital/biopsy unit

Digital mammography
with add on image system

Stand alone biopsy system

Focal Spot

acceptance

Previously covered*

Previously covered

See section 4.2.1

Leakage Radiation

acceptance

Previously covered

Previously covered

See section 4.2.2

MTF

acceptance

Previously covered

ssa

See section 4.2.6

Spatial linearity & Geometric


Distortion

acceptance

Previously covered

ssa

See section 4.2.8

Distance Calliper Accuracy

acceptance

Previously covered

ssa

See section 4.2.9

Mammography Unit Assembly


Evaluation

annual

ssa

ssa

See section 4.3.1 Note Additionally ensure X-ray tube angular locations positively locked; image
receptor and compression plate/ biopsy window free of wobble; Vernier drive and needle guide rigid
and wobble free, localisation system zeros; biopsy device properly immobilised and AEC chart
displayed see text

Collimation Assessment*

annual

ssa

ssa

FOV defined by biopsy window and is aligned centrally with digital image receptor, with tolerances of
5 mm see text.

System Resolution

annual

Previously covered

ssa

See section 4.3.3

AEC / SDNR

annual

Previously covered

ssa

See section 4.3.4 Note: technique charts should be consulted for correct factor settings. Minimum
PMMA thickness of 2 cm used for SDNR see text

Image Uniformity and Artefact


Evaluation

annual

Previously covered

ssa

See section 4.3.5 Note ROIs to be in corners of image, 10 mm from edge.

Image Quality evaluation

annual

Previously covered

ssa

See section 4.3.6 Note may use ACR mini digital stereotactic phantom see text for revised scoring

Ghost image evaluation

annual

Previously covered

ssa

See section 4.3.7

System Linearity & Noise


Analysis

annual

Previously covered

Previously covered

See section 4.3.8

kVp performance

annual

Previously covered

Previously covered

See section 4.3.9

HVL

annual

Previously covered

Previously covered

See section 4.3.10

Mean Glandular Dose

annual

ssa

ssa

See section 4.3.11 Note; see technique chart for factors used in dose calculations.

Exposure time

annual

Previously covered

Previously covered

See section 4.3.12

Viewbox and room luminance

annual

ssa

ssa

See section 4.3.13

Monitor Performance

annual

Previously covered

ssa

See section 4.3.14

Printer (Hardcopy)

annual

Previously covered

ssa

See section 4.3.15

Localisation accuracy test*

annual

ssa

ssa

*test previously completed as part of mammography tests


ssa see Stand alone biopsy units

43

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0

Appendix 6

Summary of criteria in terms of CR exposure indicators

A number of companies currently manufacture CR units for use in mammography and they have developed unique exposure indicators. Reviews
of these indicators, with a comparison between the different manufacturers, have been reported in the literature 9,41 The table below can be used
to indicate the test criteria that should be applied in terms of the current CR exposure indicators.
Tolerance in terms of CR exposure indicator
Agfaxx
5% in SAL or 430 in SAL
log or 580 in PVL log16 of
baseline
3.2.14. AEC Calibration Test
Air kerma (dose) to the plate for each of the three thicknesses of PMMA
10% in S# of baseline for
40 units in EI of
5% in the SAL , or 430 in
be within 10% of the baseline value for each thickness
each thickness
baseline for each
SAL log or 580 in PVI
thickness
log16 of baseline for each
thickness
3.2.17. Cassette Image Plate Condition & Interplate
Air kerma (dose) to individual plate should differ from mean for that size
S# for individual plates
EI for individual plate
SAL for individual plates
Sensitivity Variation (also 4.3.5)
by less than 5%
should be within 5% of
should be within 20
should be within 2.5% or
Difference in mean air kerma (dose) to plates of different sizes <20%
mean for same size
units of mean for same
SAL log should be within
S# difference for two
size
220 or PVI log16 should be
different plate sizes <20%
EI difference for two
within 290 of mean for
different plate sizes
same size
<100 units
SAL difference <10% or
SAL log difference < 1000,
or PVI log16 < 1300 for two
different plate sizes,
4.3.8. System Linearity & Noise Analysis
R2 value of appropriate plot of exposure indicator versus ESAK should be
Plot S# versus reciprocal of Plot EI versus log
Plot SAL versus
>0.99
ESAK
(ESAK)
SQRT(ESAK) or SAL log
versus log(ESAK) or PVI log
16 versus log(ESAK)
4.3.16 Exposure Indicator Calibration & Image
Under specified conditions (see Table 2) Exposure Indicator must meet
S# = 120 20
EI = 2300 100
SAL = 1130 100
Fading
criteria outlined in columns to right
SAL log = 21600 1000
PVI log 16 = 41100 1300
XX
Agfa have recently indicated that the preferred exposure indices to use with mammography plates are SAL log (sometimes called PVI log15) or PVI log16, the actual choice being dictated by software version and
plate type. SAL may be used in some old software versions and LgM should not be used.
Test
3.2.7. Image quality evaluation

Test criteria
Air kerma (dose) to the plate should not change by greater than 10%

44

Fuji, Philips & Konica


10% in S# of baseline

Kodak (Carestream)
40 units in EI of
baseline

Date of issue: 20th July 2012

Heggie et al ACPSEM Position Paper: Digital Mammography V3.0

medical imaging systems: Executive summary of AAPM


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